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

Who is this study for? Treatment naïve women with newly diagnosed breast cancer
What treatments are being studied? [11C]PiB and 18F-labeled DPA-714 PET scan
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: No
View:

‣ 50 years of age or older

‣ Female gender

‣ Newly diagnosed treatment naïve women with breast cancer that meet the following criteria:

‣ Stage IIA: Any 1 of these conditions:

‣ 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).

‣ The tumor is 20mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0).

‣ 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:

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

‣ The tumor is larger than 50mm but has not spread to the axillary lymph nodes (T3, N0, M0).

‣ StageIIIA:

• 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).

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

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

Locations
United States
Alabama
The University of Alabama at Birmingham
Recruiting
Birmingham
Contact Information
Primary
Jonathan McConathy, MD, PhD
jmcconathy@uabmc.edu
205-996-7115
Backup
April Riddle, BS RT
ariddle@uabmc.edu
205-934-6504
Time Frame
Start Date: June 1, 2023
Estimated Completion Date: July 1, 2025
Participants
Target number of participants: 20
Treatments
Experimental: Women with stage 1-4 newly diagnosed breast cancer
Authors
Jonathan McConathy, Pradeep Bhambhvani, Nabell Lisle, Triebel Gerstenecker Kristen, Nabors Burt, Falkson Carla, Jeffers Charlotte Denise, Lancaster Rachel, Krontiras Helen, Parker Catherine, Rocque Gabrielle, Stringer-Reasor Erica, Keene Kimberly, Gagandeep Choudhary, Lapi Suzanne
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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