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RECRUITING
NCT04167969
PHASE1

The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2021-02-17

Completion Date

2026-11

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, or (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots

Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, up to 48 hours before surgery.

DIAGNOSTIC_TEST

PET/MRI/fluorescence imaging

Imaging will be performed using the GE Signa PET/MRI.

OTHER

Blood and urine sampling

Staff will perform the IV blood draws and collect urine samples

PROCEDURE

laparoscopic 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.

Locations (2)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States