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Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364672
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

Brief Summary:

This study will use a PET/MRI scanner and an investigational radioactive drug called [F-18]DPA-714 that measures inflammation in the brain, also called neuroinflammation, before chemotherapy and after 3 to 6 cycles of chemotherapy given as part of your clinical care. In addition, this study will use a PET/MRI scanner with an investigational radioactive drug called [C-11]PiB that measures the amount of abnormal protein (called beta-amyloid) in the brain that is a marker of Alzheimer's disease pathology.

One of the most common complaints among breast cancer survivors is cognitive or memory problems especially in older adults. Researchers need to better understand the mechanisms and risk factors for cognitive problems in order to address this problem. This study seeks to examine two mechanisms, neuroinflammation and amyloid deposition, that have been suggested in other age-related cognitive disorders. This study may help physicians and researchers develop new treatments to protect the brain in cancer patients. UAB plans to enroll 20 participants in this study.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: [11C]PiB and 18F-labeled DPA-714 PET scan Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Breast Cancer
Estimated Study Start Date : December 31, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Women with stage 1-4 newly diagnosed breast cancer Drug: [11C]PiB and 18F-labeled DPA-714 PET scan
One PET with [11C]PiB and One PET with [18F]DPA-714 before chemotherapy treatment begins. One more PET with [18F]DPA-714 after completion of 3-6 cycles of chemotherapy.




Primary Outcome Measures :
  1. Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using PET ligand [F-18]DPA-714. [ Time Frame: Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks) ]

Secondary Outcome Measures :
  1. Correlate cognitive testing and self-reporting before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy. [ Time Frame: After pre-study visit and before starting chemotherapy ]

    Cognitive testing:

    Hopkins Verbal Learning Test-Revised (HVLT-R), 10/36 Spatial Recall Test Trail Making Test Part A, PASAT Controlled Oral Word Association Test (COWAT) Trail Making Test Part B and the Night Out Task (NOT)

    Self-report measures:

    Compensation Strategy Questionnaire (Ecomp) Cognitive Failures Questionnaire HADS Distress Thermometer FACT




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years of age or older
  2. Female gender
  3. Newly diagnosed treatment naïve women with breast cancer that meet the following criteria:

Stage IIA: Any 1 of these conditions:

  1. There is no evidence of a tumor in the breast, but the cancer has spread to 1 to 3 axillary lymph nodes. It has no spread to distant parts of the body. (T0, N1, M0).
  2. The tumor is 20mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0).
  3. The tumor is larger then 20mm but not larger than 50mm and has not spread to the axillary lymph nodes (T2, N1, M0).

Stage IIB: Either of these conditions:

  1. The tumor is larger than 20mm but not larger then 50mm and had spread to 1 to 3 axillary lymph nodes (T2, N1, M0).
  2. The tumor is larger than 50mm but has not spread to the axillary lymph nodes (T3, N0, M0).

StageIIIA:

1.The cancer of any size has spread to 4 to 9 axillary lymph nodes or to internal mammary lymph nodes. It has not spread to other parts of the body (T0, T1, T2, N2, M0). Stage IIIA may also be a tumor larger than 50mm that has spread to 1 to 3 axillary lymph nodes (T3, N1, M0).

4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.

5. English is primary language 6. Planned neoadjuvant chemotherapy with either a taxane or an anthracycline drug

Exclusion Criteria:

  1. Contraindication to PET/MRI, including claustrophobia
  2. Pregnancy
  3. Lactation
  4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
  5. Chronic infectious disease (e.g. HIV, HCV)
  6. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease
  7. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
  8. Blood or blood clotting disorder
  9. Cancer that has metastasized to the brain
  10. Positive urine β-hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of [18F]DPA-714 and [11C]PiB.
  11. Currently enrolled in a clinical trial utilizing experimental therapies.
  12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
  13. Prior brain tumor or other neurological condition known to affect cognition
  14. A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364672


Contacts
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Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmcconathy@uabmc.edu
Contact: April Riddle, BS RT 205-934-6504 ariddle@uabmc.edu

Locations
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United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Contact: Jonathan McConathy, MD, PhD    205-996-7115    jmcconathy@uabmc.edu   
Contact: April Riddle, BS RT    205-934-6504    ariddle@uabmc.edu   
Sub-Investigator: Pradeep Bhambhvani, MD         
Sub-Investigator: Gagandeep Choudhary, MD         
Sub-Investigator: Jeffers Charlotte Denise, RPh         
Sub-Investigator: Lapi Suzanne, PhD         
Sub-Investigator: Nabors Burt, MD         
Sub-Investigator: Stringer-Reasor Erica, MD         
Sub-Investigator: Rocque Gabrielle, MD         
Sub-Investigator: Triebel Gerstenecker Kristen, PsyD         
Sub-Investigator: Krontiras Helen, MD         
Sub-Investigator: Falkson Carla, MD         
Sub-Investigator: Nabell Lisle, MD         
Sub-Investigator: Keene Kimberly, MD         
Sub-Investigator: Lancaster Rachel, MD         
Sub-Investigator: Parker Catherine, MD         
Principal Investigator: Jonathan McConathy, MD, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04364672    
Other Study ID Numbers: R20-003
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders