Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
Summary
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.
Arms & interventions
- Drug(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer
Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
- Diagnostic TestPET/MRI/fluorescence imaging
Imaging will be performed using the GE Signa PET/MRI.
- OtherBlood and urine sampling
Staff will perform the IV blood draws and collect urine samples
- Procedurelaparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection
Surgery will be performed within 24 h of the third PET/MRI scan.
- Drug89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots
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
Outcome measures
Primary
Side effects
Will be described using CTCAE version 5 criteria.
Time frame: 1 year
Eligibility criteria
Study locations (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065