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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04271436
• Other study ID #: 201909060
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Richard L Wahl, M.D.
• Phone: 314-362-7100
• Email: rwahl[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in FDG uptake	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	Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
Secondary	Change in FDG uptake	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	Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
Secondary	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)

External Links

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