Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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) rs
- •English is primary language
- •Planned neoadjuvant chemotherapy with platinum and taxane drugs
排除标准
- •Contraindication to MRI
- •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 rs
- •Prior brain tumor or other neurological condition known to affect cognition
- •A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24
研究组 & 干预措施
treatment naivete women with stage 1-4 newly diagnosed ovarian
干预措施: [11C]PiB and 18F-labeled DPA-714 PET scan (Drug)
结局指标
主要结局
Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.
时间窗: Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
次要结局
- 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.(Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks))
研究者
Jonathan E McConathy
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics Affiliation: University of Alabama at Birmingham Collaborators:
University of Alabama at Birmingham