Clinical trial · Interventional

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

NCT04542603CI-TRIAL-00076502withdrawnPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): No recruitment/enrollment and funding expired.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
[11C]PiB and 18F-labeled DPA-714 PET scan	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
treatment naivete women with stage 1-4 newly diagnosed ovarian
interventionNames
1. Drug: [11C]PiB and 18F-labeled DPA-714 PET scan

Primary outcomes (1)

measure
Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.
timeFrame
Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)

Secondary outcomes (1)

measure
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.
timeFrame
Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 50 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.