Ovarian Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Study ID:

NCT04542603

Recruitment Status:

Withdrawn

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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The University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
April Riddle, BS RT
Contact
205-934-6504
[email protected]
For, BS
Contact
Jonathan McConathy, MD, PhD
Principal Investigator
Kerri Bevis, MD
Sub-Investigator
Pradeep Bhambhvani, MD
Sub-Investigator
Gagandeep Choudhary, MD
Sub-Investigator
Warner Huh
Sub-Investigator
Charlotte Denise Jeffers, RPh
Sub-Investigator
Kenneth Kim, MD
Sub-Investigator
Suzanne Lapi, PhD
Sub-Investigator
Charles Leath, MD
Sub-Investigator
Margaret Liang, MD
Sub-Investigator
L. Burt Nabors, MD
Sub-Investigator
John Straughn, MD
Sub-Investigator
Kristen Tribel (Gerstenecker), PsyD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Study ID:

NCT04542603

Recruitment Status:

Withdrawn

Sponsor:


University of Alabama at Birmingham

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