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

April 23, 2024 updated by: Jonathan E McConathy, University of Alabama at Birmingham
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • The University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment naivete women with stage 1-4 newly diagnosed ovarian
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.
Time Frame: Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jonathan McConathy, MD, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R20-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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