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Low accrual
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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT + PET/MR | Experimental | -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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET/CT | Device | A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in FLT uptake |
| Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month) |
| Change in FLT uptake |
| Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FDG uptake |
| Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month) |
| Change in FDG uptake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Wahl, M.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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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.
Beginning 3 months and ending 10 years following article publication.
Proposals should be submitted directly to rwahl@wustl.edu.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| FLT PET/CT | Device | . A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure. |
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| PET/MR | Device | MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable. |
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| [F-18] flurothymidine | Drug | -Radiopharmaceutical |
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| 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) | From baseline to the end of second cycle of treatment (estimated to be 2 months) |