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Practice Procedure for 99mTc-Sulfur Nanocolloid Lymphatic Drainage Mapping in Prostate Cancer Using SPECT-CT (Single Photon Emission Computed Tomography / Computed Tomography)

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

- Male

- Age ≥ 18 years

- Diagnosis of definitive high-risk prostate cancer

- Clinically eligible and scheduled for definitive IMRT treatment with pelvic lymph
nodal radiation (not a study procedure)

- At least one of the following risk factors:

1. Pathologically confirmed pelvic nodal involvement;

2. Enlarged pelvic lymph nodes (greater than 1 cm in the short axis) visible on CT
or MRI images, or

3. Greater than 15% risk of lymph node involvement calculated using the equation:
Risk of positive nodes (%) = (2/3) prostate specific antigen (PSA) + [(Gleason
score - 6)] × 10]. This formula is used to estimate the pathologic stage of
prostate cancer with preoperative prostate specific antigen (PSA) and Gleason
score, and adopted by many radiation oncology clinics, including our own
radiation oncology physicians.

- Ability to give written informed consent and willingness to comply with the
requirements of the protocol

Exclusion Criteria:

• Any condition that compromises compliance with the objectives and procedures of this
protocol, as judged by the principal investigator

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection

Outcome Description:

Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.

Outcome Time Frame:

1 day

Safety Issue:


Principal Investigator

Youngho Seo, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:

CC085513, H46038-33934



Start Date:

November 2009

Completion Date:

December 2010

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Prostatic Neoplasms



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115