Practice Procedure for 99mTc-Sulfur Nanocolloid Lymphatic Drainage Mapping in Prostate Cancer Using SPECT-CT (Single Photon Emission Computed Tomography / Computed Tomography)
The entire study procedure involves 1) preparation of 99mTc-sulfur nanocolloid, 2)
administration of 99mTc-sulfur nanocolloid with transrectal ultrasound guidance, 3) transfer
of the patient to the Nuclear Medicine clinic for SPECT/CT (Infinia Hawkeye, GE Healthcare)
imaging, and 4) tomographically capturing distributions of 99mTc-sulfur nanocolloid uptake
in the patient's lymphatic drainage sites within a practical image acquisition time (1-3 h
postinjection) considering the patient transit time between injection and imaging.
Administration of 99mTc-sulfur nanocolloid will be performed at the UCSF Urology clinic. The
injection will be performed following the clinically accepted method that has been
described by European investigators. 99mTc-sulfur nanocolloid imaging utilizes trace amounts
of radioactivity. 100-200 MBq (2.7-5.4 mCi) of 99mTc-sulfur nanocolloid will be
administered into two lobes of the prostate gland under transrectal ultrasound guidance with
three fractions each into peripheral and central zone of the prostatic apex, mid portion,
and base. 1% Lidocaine may be administered for local anesthesia per routine clinical
protocol as deemed appropriate by the performing urologist.
The procedure will be considered feasible if the practice procedure (from injection to
completion of imaging) is successfully implemented within 3 hours of injection (including
patient transport time). Imaging will be considered successful if radiotracer is
qualitatively detected within the prostate and local lymphatic system.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection
Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.
Youngho Seo, PhD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|