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

NCT ID: NCT04542603

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-08-31

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 naivete women with stage 1-4 newly diagnosed ovarian cancer (without brain metastases) prior to starting neoadjuvant chemotherapy treatment (baseline) and within a month of completing first 6 cycles of cytotoxic chemotherapy treatment (follow-up). In addition, we will use the well-characterized small molecule PET(Positron Emission Tomography) tracer, 11C-labeled Pittsburgh compound B (PiB) to visualize and quantify the regional brain distribution of pathological amyloid deposition at baseline only. The brain amyloid PET and MRI data acquired through this study will be correlated with cognitive test data, clinical data, genetic testing, and biospecimens collected in this study.

Conditions

Ovarian Cancer

Study Design

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

Study Groups

treatment naivete women with stage 1-4 newly diagnosed ovarian

Group Type: EXPERIMENTAL

[11C]PiB and 18F-labeled DPA-714 PET scan

Intervention Type: DRUG

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.

Interventions

[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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 50 years of age or older

2. Female gender

3. Newly diagnosed treatment naïve women with stage III/IV epithelial ovarian cancer (without known brain metastases).

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 platinum and taxane drugs

Exclusion Criteria

1. Contraindication to MRI

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 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

• Minimum Eligible Age: 50 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 Affiliation: University of Alabama at Birmingham Collaborators:

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan McConathy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

R20-100

Identifier Type: -

Identifier Source: org_study_id