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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 belowSelect...
My genetic test shows I have a specific marker (rs6971) for treatment response.
Select...
I am scheduled for initial chemotherapy with platinum and taxane drugs.
Select...
I am female.
Select...
I am 50 years old or older.
Select...
I am a woman newly diagnosed with advanced ovarian cancer and do not have brain metastases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with severe memory loss unrelated to cancer, or you score less than 24 on a memory test.My cancer has spread to my brain.I have a chronic inflammatory or autoimmune disease like MS.You should not have an MRI for medical reasons.I have a history of brain tumor or a condition affecting my thinking.My genetic test shows I have a low affinity for certain brain receptor ligands.My genetic test shows I have a specific marker (rs6971) for treatment response.I am scheduled for initial chemotherapy with platinum and taxane drugs.You have recently tested positive for pregnancy.I haven't needed treatment for an infection in the last month.I have a long-term infection like HIV or hepatitis C.I am female.I am 50 years old or older.I am a woman newly diagnosed with advanced ovarian cancer and do not have brain metastases.I have a blood or clotting disorder.
Research Study Groups:
This trial has the following groups:- Group 1: treatment naivete women with stage 1-4 newly diagnosed ovarian
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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