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

Phase 2

Withdrawn

• Conditions: Cancer
• Interventions: Device: FDG PET/CT; Device: FLT PET/CT; Device: PET/MR; Drug: [F-18] flurothymidine

• Registration Number: NCT04271436
• Lead Sponsor: Washington University School of Medicine

Brief 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".

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Study Start: 2021-04-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients must have histologically or cytologically confirmed diagnosis of cancer.
• Patients who are planned to receive checkpoint blockade therapy, per referring oncologist.
• Life expectancy ≥ 6 months and < 5 years.
• Disease that is measurable per RECIST 1.1.
• Age ≥18 years.
• Ability and willingness to provide informed consent
• Women of child-bearing potential must have a negative urinary or serum pregnancy test within 7 days of each imaging time point.

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Exclusion Criteria

• Patient receiving other investigational radiotracers within 14 days prior to FLT and FDG imaging time points.
• Patients receiving ICB in combination with chemotherapy.
• Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency. Patients requiring immunosuppressive therapy during the study will no longer be eligible.
• Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune diseases, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with a pacemaker, stainless steel aneurysm clip or any other magnetic resonance (MR) contraindicated implant or foreign body would warrant exclusion from this study. Pacemakers may be reprogrammed or turned off by the strong MRI magnetic field. Radio-frequency (RF) fields in MR can also cause severe heating of pacemaker lead tips. Steel aneurysm clips are prone to torque in the strong MR field which can displace the clips and may damage the vessel, resulting in hemorrhage, and/or death.
• Pregnant women are excluded from this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT + PET/MR	FDG PET/CT	-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.
PET/CT + PET/MR	FLT PET/CT	-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.
PET/CT + PET/MR	PET/MR	-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.
PET/CT + PET/MR	[F-18] flurothymidine	-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.

Primary Outcome Measures

Name	Time	Method
Change in FLT uptake	Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)	* 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

Secondary Outcome Measures

Name	Time	Method
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)
Change in FDG uptake	Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)	* 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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States