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1

<span class="highlight">Cognitive-Sparing</span> Stereotactic Radiosurgery for Brain Metastasis

UCSD Image-Guided <span class="highlight">Cognitive-Sparing</span> Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">cognitive-sparing</span> stereotactic radiosurgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Cognitive-sparing</span> stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">MRI scans, 4 scans within 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Cognitive</span> tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery is a targeted radiation therapy that avoids the white matter and hippocampus (parts of the brain that control memory, language, attention, and cognition).</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04343157' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
1

<span class="highlight">Cognitive-Sparing</span> Stereotactic Radiosurgery for Brain Metastasis

UCSD Image-Guided <span class="highlight">Cognitive-Sparing</span> Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions
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Nearest Location:
447 miles
Moores Cancer Center
San Diego, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04343157

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Phase II

2

Studying Speech, Movement, and Senses During Brain Surgery for Brain Metastasis

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Purpose: To study how brain tumors affect your speech, movement, and senses and to develop new methods of diagnosing brain tumors.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Cognitive</span> testing</li> <li class="seamTextUnorderedListItem">MRI and fMRI scans</li> <li class="seamTextUnorderedListItem">DTI tractograms</li> <li class="seamTextUnorderedListItem">MEG studies</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Awake brain mapping and surgery to remove brain tumor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A craniotomy is a type of brain surgery. The surgeon will remove part of your skull (cranium) to access your brain to remove the tumors.</li> <li class="seamTextUnorderedListItem">You will be awake during the craniotomy to monitor how the surgery is affecting your speech, movement, and senses. Your scalp will be anesthetized, so you will not feel the operation or any pain.</li> <li class="seamTextUnorderedListItem">You will receive <span class="highlight">cognitive</span> testing, MRI and fMRI scans, DTI tractograms, and MEG studies before and after surgery.</li> <li class="seamTextUnorderedListItem">Cognitive tests study your cognition, which is your ability to think.</li> <li class="seamTextUnorderedListItem">Magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) scans produce brain images created by magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A DTI tractogram is a type of MRI scan that produces brain images created by radio waves and magnetic fields.</li> <li class="seamTextUnorderedListItem">MEG studies measure the magnetic fields produced by your brain.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01535430' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://braintumorcenter.ucsf.edu/treatments/surgery/awake-brain-mapping-faq' target='_blank'>UCSF Brain Tumor Center: Awake Craniotomy</a> </li></ul>
2

Studying Speech, Movement, and Senses During Brain Surgery for Brain Metastasis

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
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Nearest Location:
1418 miles
University of Nebraska Medical Center
Omaha, NE

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT01535430

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Phase NA

3

Care and Monitoring at Home for People with Brain Metastasis

Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote <span class="highlight">Cognitive</span> Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on Cognition and Quality of Life in Patients With History of Cranial Radiation

Purpose: To study if giving metformin and monitoring can be done at home for people receiving brain radiation or who have previously had brain radiation.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must be planning to receive brain radiation or completed brain radiation within the last 3 years. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Metformin, by mouth, daily, 1 year</li> <li class="seamTextUnorderedListItem">FitBit wearable device</li> <li class="seamTextUnorderedListItem"><span class="highlight">Cognitive</span> tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment, 1 year</li> <li class="seamTextUnorderedListItem">FitBit wearable device</li> <li class="seamTextUnorderedListItem"><span class="highlight">Cognitive</span> tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain radiation can result in significant negative effects on cognition (the ability to clearly think, learn, and remember).</li> <li class="seamTextUnorderedListItem">Cognitive tests study your cognition, which is your ability to think.</li> <li class="seamTextUnorderedListItem">Metformin is a drug approved to treat type 2 diabetes (a condition in which the body cannot control the level of sugar in the blood).</li> <li class="seamTextUnorderedListItem">Metformin may also be used to treat cancer and improve your cognition (ability to think) and quality of life.</li> <li class="seamTextUnorderedListItem">In this study, a FitBit wearable device will be used to monitor and detect seizures.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06377696' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Care and Monitoring at Home for People with Brain Metastasis

Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote <span class="highlight">Cognitive</span> Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on Cognition and Quality of Life in Patients With History of Cranial Radiation
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06377696

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Phase II

4

Brain Surgery for Brain Metastasis and Tumor Related Epilepsy

Tumor Related Epilepsy

Purpose: To study if brain surgery reduces the number of seizures and to see how surgery affects seizures.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have no more than one brain tumor and have experienced at least one seizure associated with the tumor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for at least one week</li> <li class="seamTextUnorderedListItem">Questionnaires, <span class="highlight">cognitive</span> assessments, and seizure diary</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. </li> <li class="seamTextUnorderedListItem">Researchers think surgery may improve outcomes for people with tumor-related epilepsy by stopping seizures or reducing the number of seizures.</li> <li class="seamTextUnorderedListItem">Cognitive assessments study your cognition, which is your ability to think.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02639325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/brain-metastasis/' target='_blank'>MBCBrainMets.org: About Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/treatments-brain-metastasis/#toggle-id-7' target='_blank'>MBCBrainMets.org: Brain Metastasis Treatments</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/brain-mets/' target='_blank'>Metastastic Trial Talk: Treating Breast Cancer Brain Mets</a> </li></ul>
4

Brain Surgery for Brain Metastasis and Tumor Related Epilepsy

Tumor Related Epilepsy
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization

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ClinicalTrials.gov: NCT02639325

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Phase NA

5

Preserving <span class="highlight">Cognitive</span> Function With Whole Brain Radiation Therapy for Brain Metastases

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study

Purpose: To evaluate how well genu-sparing whole brain radiation preserves <span class="highlight">cognitive</span> function in patients with brain metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) that has not been treated with whole brain radiation therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation therapy, once a day, 5 days a week</li> <li class="seamTextUnorderedListItem"><span class="highlight">Cognitive</span> testing at baseline and at 4 , 6 and 12 months following completion of brain radiation</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation limits the radiation dose to a specific area in the brain (the genu of the corpus callosum).</li> <li class="seamTextUnorderedListItem">The genu (front part) of the corpus callosum is associated with <span class="highlight">cognitive</span> and neuropsychiatric functioning.</li> <li class="seamTextUnorderedListItem">Researchers believe that reducing damage to this area may prevent the decline of <span class="highlight">cognitive</span> and neuropsychiatric functioning.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03223922' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
5

Preserving <span class="highlight">Cognitive</span> Function With Whole Brain Radiation Therapy for Brain Metastases

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study
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Nearest Location:
2433 miles
Sibley Memorial Hospital
Washington, DC

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Visits:
Please contact the research site

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ClinicalTrials.gov: NCT03223922

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Phase NA

6

Time-Restricted Eating to Reduce <span class="highlight">Cognitive</span> Decline for People With Brain Metastases Receiving Radiation

Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes

Purpose: To study if time-restricted eating reduces <span class="highlight">cognitive</span> (ability to think) problems during radiation.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Time-restricted eating, 1 month</li> <li class="seamTextUnorderedListItem">Text messages with positive encouragement, 1 month</li> <li class="seamTextUnorderedListItem">Digital food diary, 1 month</li> <li class="seamTextUnorderedListItem">Counseling phone calls, 1-2 times every week, 1 month</li> <li class="seamTextUnorderedListItem">Brain MRI scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Text messages with healthy eating habits, 1 month</li> <li class="seamTextUnorderedListItem">Digital food diary, 1 month</li> <li class="seamTextUnorderedListItem">Brain MRI scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Time-restricted eating, a form of intermittent fasting, is eating all food within approximately 10:00am and 6:00pm, with fasting the remaining hours of the day.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06315296' target='_blank'>ClinicalTrials.gov</a> </li></ul>
6

Time-Restricted Eating to Reduce <span class="highlight">Cognitive</span> Decline for People With Brain Metastases Receiving Radiation

Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
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Nearest Location:
2519 miles
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, PA

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Visits:
3 visits within 7 months

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ClinicalTrials.gov: NCT06315296

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Phase NA

7

Mindfulness to Prevent Chemo Brain for Women with Stage I-IV Breast Cancer

Pilot Feasibility Evaluation of a Mindfulness (Mindfulness) Intervention in Women Preparing for Chemotherapy for Breast Cancer

Purpose: To study how well a mindfulness program helps prevent "chemo brain".

Who is this for?: Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mindfulness program: practice mindfulness for 2.5 hours/week for 2 months </li> <li class="seamTextUnorderedListItem">MRI scan, 1 time</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Difficulty thinking, known as <span class="highlight">cognitive</span> dysfunction or <q>chemo brain</q>, is common after chemotherapy. </li> <li class="seamTextUnorderedListItem">Mindfulness is a type of meditation that can support well-being, decrease stress, and increase awareness of the present moment without judgment. </li> <li class="seamTextUnorderedListItem">In this trial, the mindfulness program includes mindfulness of breathing and body scans, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06219434' target='_blank'>ClinicalTrials.gov</a> </li></ul>
7

Mindfulness to Prevent Chemo Brain for Women with Stage I-IV Breast Cancer

Pilot Feasibility Evaluation of a Mindfulness (Mindfulness) Intervention in Women Preparing for Chemotherapy for Breast Cancer
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Nearest Location:
2519 miles
Thomas Jefferson University Hopsital
Philadelphia, PA

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Visits:
Number of visits unavailable, over 2 months

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ClinicalTrials.gov: NCT06219434

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Phase NA

8

Coaching Program to Reduce Stress and Promote Resilience for People with Metastatic Breast Cancer

Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC PRISMMBC)

Purpose: To study the ability of the PRISM program to reduce stress and improve resilience for people with metastatic breast cancer.

Who is this for?: People with stage IV (metastatic) breast cancer who were diagnosed with metastatic disease in the last 6 months. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Promoting Resilience in Women with Breast Cancer (PRISM) program, virtual, 4 sessions in 1-2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Promoting Resilience in Women with Breast Cancer (PRISM) program helps improve 4 areas of resilience: stress management, goal setting, <span class="highlight">cognitive</span> reframing, and meaning-making.</li> <li class="seamTextUnorderedListItem">This study will compare the resilience of Black women to non-Black women.</li> <li class="seamTextUnorderedListItem">It also includes an optional family session.</li> <li class="seamTextUnorderedListItem">Each session is 30-60 minutes every 1-2 weeks.</li> <li class="seamTextUnorderedListItem">Black women with MBC have worse outcomes than white women with MBC because of social determinants of health (SDOH).</li> <li class="seamTextUnorderedListItem">Social determinants of health (SDOH) describe non-medical factors that influence your health, such as race, gender identity, education, occupation, transportation, food and health access, medication affordability, safety at home, housing, and financial stability.</li> <li class="seamTextUnorderedListItem">Reducing stress and improving resilience during MBC treatment may improve quality of life and even improve disease outcomes.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06855654' target='_blank'>ClinicalTrials.gov</a> </li></ul>
8

Coaching Program to Reduce Stress and Promote Resilience for People with Metastatic Breast Cancer

Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC PRISMMBC)
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06855654

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Phase NA

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