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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ between pre-treatment pet/ct imaging and end of cycle 2 pet/ct imaging (estimated to be 2 months)
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)
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
1,935 Previous Clinical Trials
2,299,843 Total Patients Enrolled
Richard L Wahl, M.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving immunotherapy combined with chemotherapy.I am not on immunosuppressive therapy, except for low-dose steroids for adrenal issues.I have another cancer, but it's not getting worse or needing treatment, except for certain skin cancers or treated cervical cancer.My doctor plans for me to receive immunotherapy.My cancer diagnosis was confirmed through lab tests on tissue or cell samples.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am 18 years old or older.I do not have a pacemaker, steel aneurysm clip, or any MR-unsafe implants.
Research Study Groups:
This trial has the following groups:- Group 1: PET/CT + PET/MR
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.
What risks, if any, have been associated with FLT PET/CT scans?
"Our team at Power rated FLT PET/CT's safety to be a 2, as there is existing clinical data backing its security but no evidence of the efficacy."
Answered by AI
Is enrollment for this trial currently available to participants?
"According to clinicaltrials.gov, this experiment is currently enrolling participants and has been actively edited since its initial posting on April 22nd 2021."
Answered by AI
How many participants have been admitted to this medical experiment?
"Affirmative. According to information on clinicaltrials.gov, this experiment is actively looking for participants as of April 27th 2022; it was first posted on 22nd April 2021. The objective is to enlist 30 test subjects from a single site."
Answered by AI
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