Status:
WITHDRAWN
Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT
Lead Sponsor:
Washington University School of Medicine
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hypot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04271436
Start Date
April 22 2021
End Date
January 31 2025
Last Update
January 7 2025
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