Breast Cancer Clinical Trial
Molecular Neuroimaging to Assess the Link Between Neuroinflammation and Cognitive Impairment in Breast Cancer
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 Criteria
Inclusion Criteria:
18 years of age or older
Female gender
Newly diagnosed treatment naïve women with stage II-III breast cancer that meet the following
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 not spread to distant parts of the body. (T0, N1, M0)
The tumor is 20 mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0)
The tumor is larger than 20 mm but not larger than 50 mm and has not spread to the axillary lymph nodes (T2, N0, M0)
Stage IIb: Either of these conditions
The tumor is larger than 20 mm but not larger than 50 mm and has spread to 1 to 3 axillary lymph nodes (T2, N1, M0)
The tumor is larger than 50 mm but has not spread to the axillary lymph nodes (T3, N0, M0)
Stage IIIA: 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, or T3, N2, M0. Stage IIIA may also be a tumor larger than 50 mm that has spread to 1 to 3 axillary lymph nodes (T3, N1, M0)
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Planned neoadjuvant chemotherapy that includes a taxane and/or an anthracycline drug as part of the treatment regimen.
Exclusion Criteria:
Contraindications to PET/MRI, including claustrophobia
Low-affinity binder for TSPO ligands when genotyping is available prior to PET imaging
Pregnancy
Lactation
Individuals who are unable to participate in the imaging portion due to the severity of their medical condition
Chronic infectious disease (e.g., HIV, HCV)
Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease
Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
Blood or blood clotting disorder
Cancer that has metastasized to the brain
Positive urine β-hCG test day of the procedure or a serum-hCG test within 48 hours prior to the administration of [18F]DPA-714
Currently enrolled in a clinical trial utilizing experimental therapies.
Prior brain tumor or other neurological condition known to affect cognition
A diagnosis of dementia unrelated to cancer
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There is 1 Location for this study
Birmingham Alabama, 35249, United States More Info
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