Breast Cancer Clinical Trial

Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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:

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:

Contraindication to PET/MRI, including claustrophobia
Pregnancy
Lactation
Individuals who are unable to participate in the imaging portion due to 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 procedure or a serum hCG test within 48 hours prior to the administration of [18F]DPA-714 and [11C]PiB.
Currently enrolled in a clinical trial utilizing experimental therapies.
Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
Prior brain tumor or other neurological condition known to affect cognition
A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT04364672

Recruitment Status:

Recruiting

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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The University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Jonathan McConathy, MD, PhD
Contact
205-996-7115
[email protected]
April Riddle, BS RT
Contact
205-934-6504
[email protected]
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
Sub-Investigator
Jonathan McConathy, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT04364672

Recruitment Status:

Recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

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