Molecular Neuroimaging to Assess the Link Between Neuroinflammation and Cognitive Impairment in Breast Cancer

NCT ID: NCT04364672

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-07-01

Brief Summary

This clinical study will use the small molecule translocator protein (TSPO) ligand, 18F-labeled DPA-714, to visualize and quantify neuroinflammation in treatment naive women with stage II-III newly diagnosed breast cancer (without brain metastases) prior to starting neoadjuvant chemotherapy treatment (baseline) and within 4 weeks after finishing neoadjuvant chemotherapy (NACT) with at least 2 cycles administered and before surgery. . The TSPO PET and MRI data acquired through this study will be correlated with cognitive test data, clinical data, and genetic testing collected in this study. We will enroll 20 participants in this study (20 participants with breast cancer).

Study Aim 1:

To examine the association between neuroinflammation and cancer related cognitive impairment (CRCI) in women with breast cancer before and after undergoing chemotherapy treatment.

(Hypothesis 1): Treatment-naïve women with Stage II-III breast cancer (without known brain metastases) will experience increased amount of neuroinflammation and greater cognitive decline after completing neodjuvant Chemotherapy Treatment (NACT).

(Hypothesis 2): Greater levels of neuroinflammation as measured by the amount and distribution of [18F]DPA-714 in the brain using PET/MRI after completing NACT will be associated with lower levels of cognitive functioning as measured by self-report and/or objective cognitive impairment/change.

Neuroinflammation will be measured using PET with tracer [18F]DPA-714 using a simultaneous PET/MRI system, and cognitive functioning will be measured with self-report and objective neuropsychological measures.

Exploratory Aim 2:

To investigate the relationships between CRCI and quality of life (QOL) and everyday functioning in breast cancer survivors after completing chemotherapy treatment.

For this Aim, we will assess QOL using self-report measures.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Women with stage 1-4 newly diagnosed breast cancer

Group Type: EXPERIMENTAL

18F-labeled DPA-714 PET scan

Intervention Type: DRUG

One PET with \[18F\]DPA-714 before chemotherapy treatment begins. One more PET with \[18F\]DPA-714 within 4 weeks after completing NACT including at least 2 cycles administered; before surgery

Interventions

18F-labeled DPA-714 PET scan

One PET with \[18F\]DPA-714 before chemotherapy treatment begins. One more PET with \[18F\]DPA-714 within 4 weeks after completing NACT including at least 2 cycles administered; before surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or older

2. Female gender

3. 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)

4. English is the primary language

5. Planned neoadjuvant chemotherapy that includes a taxane and/or an anthracycline drug as part of the treatment regimen.

Exclusion Criteria

1. Contraindications to PET/MRI, including claustrophobia

2. Low-affinity binder for TSPO ligands when genotyping is available prior to PET imaging

3. Pregnancy

4. Lactation

5. Individuals who are unable to participate in the imaging portion due to the severity of their medical condition

6. Chronic infectious disease (e.g., HIV, HCV)

7. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease

8. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation

9. Blood or blood clotting disorder

10. Cancer that has metastasized to the brain

11. 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

12. Currently enrolled in a clinical trial utilizing experimental therapies.

13. Prior brain tumor or other neurological condition known to affect cognition

14. A diagnosis of dementia unrelated to cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jonathan E McConathy

M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R20-003

Identifier Type: -

Identifier Source: org_study_id