NCT04271436

Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT

Early Assessment of Response to Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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".

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	FDG PET/CT	A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure.
DEVICE	FLT PET/CT	. A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure.
DEVICE	PET/MR	MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.
DRUG	[F-18] flurothymidine	-Radiopharmaceutical

Timeline

• Start date: 2021-04-22
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2020-02-17
• Last updated: 2025-01-07

Regulatory

• FDA-regulated drug study