search
Back to results

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

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]PiB and 18F-labeled DPA-714 PET scan
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment naivete women with stage 1-4 newly diagnosed ovarian

Arm Description

Outcomes

Primary Outcome Measures

Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.

Secondary Outcome Measures

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.

Full Information

First Posted
August 13, 2020
Last Updated
June 29, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT04542603
Brief Title
Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer
Official Title
Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2025 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment naivete women with stage 1-4 newly diagnosed ovarian
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[11C]PiB and 18F-labeled DPA-714 PET scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 years of age or older Female gender Newly diagnosed treatment naïve women with stage III/IV epithelial ovarian cancer (without known brain metastases). High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. English is primary language Planned neoadjuvant chemotherapy with platinum and taxane drugs Exclusion Criteria: Contraindication to MRI 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan McConathy, MD, PhD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle, BS RT
Phone
205-934-6504
Email
ariddle@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Riddle, BS RT
Phone
205-934-6504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name & Degree
For, BS
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kerri Bevis, MD
First Name & Middle Initial & Last Name & Degree
Pradeep Bhambhvani, MD
First Name & Middle Initial & Last Name & Degree
Gagandeep Choudhary, MD
First Name & Middle Initial & Last Name & Degree
Warner Huh
First Name & Middle Initial & Last Name & Degree
Charlotte Denise Jeffers, RPh
First Name & Middle Initial & Last Name & Degree
Kenneth Kim, MD
First Name & Middle Initial & Last Name & Degree
Suzanne Lapi, PhD
First Name & Middle Initial & Last Name & Degree
Charles Leath, MD
First Name & Middle Initial & Last Name & Degree
Margaret Liang, MD
First Name & Middle Initial & Last Name & Degree
L. Burt Nabors, MD
First Name & Middle Initial & Last Name & Degree
John Straughn, MD
First Name & Middle Initial & Last Name & Degree
Kristen Tribel (Gerstenecker), PsyD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined

Learn more about this trial

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

We'll reach out to this number within 24 hrs