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

NCT ID: NCT04271436

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2025-01-31

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".

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PET/CT + 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.

Group Type: EXPERIMENTAL

FDG PET/CT

Intervention Type: DEVICE

A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure.

FLT PET/CT

Intervention Type: DEVICE

. A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure.

PET/MR

Intervention Type: DEVICE

MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.

[F-18] flurothymidine

Intervention Type: DRUG

-Radiopharmaceutical

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

PET/MR

MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.

Intervention Type: DEVICE

[F-18] flurothymidine

-Radiopharmaceutical

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L Wahl, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201909060

Identifier Type: -

Identifier Source: org_study_id