Memorial Sloan Kettering Cancer Center
New York, 10065, United States
NCT Number: NCT03631017
The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 1 / Phase 2
New York, 10065, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part 1:
Part 2
Exclusion criteria
o Platelets <75K/mcL
o Creatinine > 2.0 x ULN
injection of a microdose (< 100 ug) of [18F]- PARPi
Patients will be injected with approximately 10 mCi of [18F]PARPi and a dynamic PET scan of will be acquired for approximately 30 minutes. A second body PET/CT scan will be started approximately 60 min post injection, and a third PET/CT scan will be started at approximately 120 min post injection. The first (dynamic) and the second (body) PET/CT scan will use "ultra -low dose" CT scan for attenuation correction. The last PET/CT scan will be performed with the investigator's regular clinical low-dose CT settings.
Time frame: 2 years
according to Common Terminology Criteria for Adverse Events (CTCAE 4.0).
Memorial Sloan Kettering Cancer Center
Other
Safety, Biodistribution and Radiation Dosimetry of [18F]PARPi
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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