RECRUITING

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

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Conditions

Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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".

Official Title

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

Quick Facts

Study Start:2021-04-22
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04271436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have histologically or cytologically confirmed diagnosis of cancer.
  2. * Patients who are planned to receive checkpoint blockade therapy, per referring oncologist.
  3. * Life expectancy ≥ 6 months and \< 5 years.
  4. * Disease that is measurable per RECIST 1.1.
  5. * Age ≥18 years.
  6. * Ability and willingness to provide informed consent
  7. * Women of child-bearing potential must have a negative urinary or serum pregnancy test within 7 days of each imaging time point.
  1. * Patient receiving other investigational radiotracers within 14 days prior to FLT and FDG imaging time points.
  2. * Patients receiving ICB in combination with chemotherapy.
  3. * Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency. Patients requiring immunosuppressive therapy during the study will no longer be eligible.
  4. * 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.
  5. * 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
  6. * 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.
  7. * Pregnant women are excluded from this study

Contacts and Locations

Study Contact

Richard L Wahl, M.D.
CONTACT
314-362-7100
rwahl@wustl.edu

Principal Investigator

Richard L Wahl, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Richard L Wahl, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-22
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2021-04-22
Study Completion Date2025-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer