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Checkpoint Inhibitor

Immune Checkpoint Blockade Therapy Monitoring with PET Scans for Cancer

Phase 2
Recruiting
Led By Richard L Wahl, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between pre-treatment pet/ct imaging and end of cycle 2 pet/ct imaging (estimated to be 2 months)
Awards & highlights

Study Summary

This trial will use PET scans to compare how effective different cancer treatments are.

Who is the study for?
This trial is for adults with cancer who have a life expectancy of at least 6 months but less than 5 years, and whose disease can be measured. They must be starting immune checkpoint blockade therapy and not be on other investigational drugs or immunosuppressives. Pregnant women, those with certain medical conditions or metal implants incompatible with MRI are excluded.Check my eligibility
What is being tested?
The study tests if PET/CT and PET/MR imaging can predict the success of immune checkpoint blockade therapy in cancer patients by measuring changes in tumor uptake of FLT and FDG after treatment cycles. Responders are expected to show an initial increase followed by a decrease in uptake.See study design
What are the potential side effects?
While the trial focuses on imaging techniques rather than drug side effects, potential risks include exposure to radiation from PET scans and discomfort or allergic reactions related to contrast agents used during imaging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between pre-treatment pet/ct imaging and end of cycle 2 pet/ct imaging (estimated to be 2 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between pre-treatment pet/ct imaging and end of cycle 2 pet/ct imaging (estimated to be 2 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in FLT uptake
Secondary outcome measures
Change in FDG uptake
Change in apparent diffusion coefficient (ADC) on diffusion-weighted MRI (DW-MRI)

Trial Design

1Treatment groups
Experimental Treatment
Group I: PET/CT + PET/MRExperimental Treatment4 Interventions
-Eligible patients will have imaging assessments (as part of the study) performed at three time-points: pre-treatment, following cycle 1 of treatment, and following cycle 2 of treatment. Baseline FDG PET/CT will be a standard-of-care procedure. If possible, PET/CT imaging will be performed, followed immediately by PET/MR imaging during each imaging session. At minimum, PET/MR should be obtained at least once during each time-point (i.e. either during the FDG or FLT procedure). FDG imaging and FLT imaging should be performed at least 24 hours apart and no more than 7 days apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDG PET/CT
2014
N/A
~170
FLT PET/CT
2014
N/A
~10
PET/MR
2018
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,441 Total Patients Enrolled
Richard L Wahl, M.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
103 Total Patients Enrolled

Media Library

ICB Therapy (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04271436 — Phase 2
Cancer Research Study Groups: PET/CT + PET/MR
Cancer Clinical Trial 2023: ICB Therapy Highlights & Side Effects. Trial Name: NCT04271436 — Phase 2
ICB Therapy (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04271436 — Phase 2
~5 spots leftby Jan 2025
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