Purpose

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

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35249
Contact:
Jonathan McConathy, MD, PhD
205-996-7115
jmcconathy@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Jonathan McConathy, MD, PhD
205-996-7115
jmcconathy@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.