(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer
DrugPatients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
NCT Number: NCT04167969
The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 1
Memorial Sloan Kettering Cancer Center, New York, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Primary RP + PLND
Salvage PLND
Exclusion criteria
°This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
Imaging will be performed using the GE Signa PET/MRI.
Staff will perform the IV blood draws and collect urine samples
Surgery will be performed within 24 h of the third PET/MRI scan.
Patients (up to 6) will receive an intravenous (IV) injection of approximately 5-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer within 24-48 h before surgery. Patients will then undergo one preoperative PET/MR imaging
Time frame: 1 year
Will be described using CTCAE version 5 criteria.
Contact information is provided by the study sponsor or research team.
Memorial Sloan Kettering Cancer Center
Other
Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
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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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