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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04542603
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Alabama at Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jonathan McConathy, MD, PhD
Principal Investigator Affiliation University of Alabama at Birmingham
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ovarian Cancer
Arms & Interventions

Arms

Experimental: treatment naivete women with stage 1-4 newly diagnosed ovarian

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

The University of Alabama at Birmingham

Birmingham, Alabama, 35249

Site Contact

April Riddle, BS RT

ariddle@uabmc.edu

205-934-6504

Stay Informed & Connected