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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
Must not have
Cancer that has metastasized to the brain
Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my brain.
Select...
I have a chronic inflammatory or autoimmune disease like MS.
Select...
I have a history of brain tumor or a condition affecting my thinking.
Select...
My genetic test shows I have a low affinity for certain brain receptor ligands.
Select...
I have a long-term infection like HIV or hepatitis C.
Select...
I have a blood or clotting disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,656 Previous Clinical Trials
2,444,375 Total Patients Enrolled
13 Trials studying Ovarian Cancer
2,255 Patients Enrolled for Ovarian Cancer
Jonathan McConathy, MD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
174 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.