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Small Molecule PET Tracer

PET Scans for Cognitive Impairment in Ovarian Cancer

Phase 1
Waitlist Available
Led By Jonathan McConathy, MD, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971
Planned neoadjuvant chemotherapy with platinum and taxane drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
Awards & highlights

Study Summary

This trial will use a new imaging technique to study neuroinflammation and brain amyloid deposition in women with ovarian cancer.

Who is the study for?
This trial is for women over 50 with newly diagnosed stage III/IV ovarian cancer, who speak English and are about to start chemotherapy. They must be high or mixed affinity binders for TSPO ligands as per their genetics. Excluded are those with brain metastases, prior neurological conditions affecting cognition, chronic diseases like HIV or MS, current participation in other experimental trials, dementia unrelated to cancer, blood disorders, or recent severe infections.Check my eligibility
What is being tested?
The study tests two PET scan tracers: [11C]PiB and 18F-labeled DPA-714. It aims to visualize neuroinflammation before and after chemotherapy in ovarian cancer patients without brain metastases and amyloid deposits at baseline only. The scans' results will be compared with cognitive tests and clinical data.See study design
What are the potential side effects?
While the document does not specify side effects of the PET scan tracers directly, typical risks may include allergic reactions to the tracer substance used during imaging procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My genetic test shows I have a specific marker (rs6971) for treatment response.
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I am scheduled for initial chemotherapy with platinum and taxane drugs.
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I am female.
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I am 50 years old or older.
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I am a woman newly diagnosed with advanced ovarian cancer and do not have brain metastases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.
Secondary outcome measures
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatment naivete women with stage 1-4 newly diagnosed ovarianExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,566 Previous Clinical Trials
2,268,367 Total Patients Enrolled
14 Trials studying Ovarian Cancer
1,418 Patients Enrolled for Ovarian Cancer
Jonathan McConathy, MD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
149 Total Patients Enrolled

Media Library

[11C]PiB (Small Molecule PET Tracer) Clinical Trial Eligibility Overview. Trial Name: NCT04542603 — Phase 1
Ovarian Cancer Research Study Groups: treatment naivete women with stage 1-4 newly diagnosed ovarian
Ovarian Cancer Clinical Trial 2023: [11C]PiB Highlights & Side Effects. Trial Name: NCT04542603 — Phase 1
[11C]PiB (Small Molecule PET Tracer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542603 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this clinical trial still open?

"Reports from clinicaltrials.gov demonstrate that the recruitment for this trial has been suspended since June 9th, 2022 despite being initially posted on June 1st 2025. Fortunately, there are currently over one thousand other studies recruiting patients at present."

Answered by AI

Could you explain what potential risks may accompany [11C]PiB and 18F-labeled DPA-714 PET scans?

"There is limited evidence for the safety and effectiveness of [11C]PiB and 18F-labeled DPA-714 PET scan, thus it received a score of 1 on our evaluation metrics."

Answered by AI
~13 spots leftby Aug 2026