Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer
Reason given: No recruitment/enrollment and funding expired.
Key facts
- Phase
- Phase 1
Trial details
- Who runs it
- University of Alabama at Birmingham
- Trial code
- NCT04542603
- Record updated
- 25 April 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Currently enrolled in a clinical trial utilizing experimental therapies; Prior brain tumor or other neurological condition known to affect cognition; 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; A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24; 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; Contraindication to MRI; Pregnancy; Lactation; Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.