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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: July 1, 2022
- 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.
Arms, Groups and Cohorts
- Experimental: Women with stage 1-4 newly diagnosed breast cancer
Clinical Trial Outcome Measures
- 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)
- Measure cognitive impairment by calculating the concentration and regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants prior to starting chemotherapy.
- Time Frame: After pre-study visit and before starting chemotherapy
Participating in This Clinical Trial
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).
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
1. Contraindication to PET/MRI, including claustrophobia
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
Gender Eligibility: Female
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Alabama at Birmingham
- Provider of Information About this Clinical Study
- Principal Investigator: Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics – University of Alabama at Birmingham
- Overall Contact(s)
- Jonathan McConathy, MD, PhD, 205-996-7115, email@example.com
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