A Phase 2 interventional study of FDG PET/CT and FLT PET/CT in Cancer, sponsored by Washington University School of Medicine. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Other
In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate the hypothesis that participants receiving immune checkpoint blockade (ICB) therapy, who ultimately achieve clinical benefit, will show an increase, or "FLARE", in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in comparison to the participants classified as "non-responders".
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-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.
Device: FDG PET/CT · Device: FLT PET/CT · Device: PET/MR · Drug: [F-18] flurothymidine
A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure.
. A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure.
MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.
-Radiopharmaceutical
Change in FLT uptake
* Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements * Changes in FLT uptake will be compared between the two groups
Time frame: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
Change in FLT uptake
* Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements * Changes in FLT uptake will be compared between the two groups
Time frame: Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
Change in FDG uptake
* Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements * Changes in FDG uptake will be compared between the two groups
Time frame: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
Change in FDG uptake
* Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements * Changes in FDG uptake will be compared between the two groups
Time frame: Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
Change in apparent diffusion coefficient (ADC) on diffusion-weighted MRI (DW-MRI)
Time frame: From baseline to the end of second cycle of treatment (estimated to be 2 months)
No study locations are listed for this record.
Plan to share: Yes — Data may be shared with other researchers. The researchers may be doing research at Washington University, at other research centers and institutions, or industry sponsors of research. Data may also be shared with large data repositories. The researchers may be doing research in areas similar to this research or in other unrelated areas.
Supporting information: Study protocol, Icf, Csr
This study is withdrawn, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine