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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04542603
• Other study ID #: R20-100
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2025
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Cognitive Dysfunction
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• [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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.		Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
Secondary	Correlate cognitive impairment before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy.		Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)