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

NCT04271436 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 201909060
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)

Secondary Outcomes (3)

• 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

  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)

Study Arms (1)

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.

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

Interventions

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.

PET/CT + PET/MR

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.

PET/CT + PET/MR

PET/MR DEVICE

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

PET/CT + PET/MR

[F-18] flurothymidine DRUG

-Radiopharmaceutical

PET/CT + PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant women are excluded from this study

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Richard L Wahl, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: April 22, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 3 months and ending 10 years following article publication.
• Access Criteria: Proposals should be submitted directly to rwahl@wustl.edu.