Feasibility of Using SPECT/CT Imaging to Map Lymphatic Drainage Patterns in Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008969
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : February 2, 2012
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to develop a practice procedure for lymphatic drainage mapping with the intent of providing a new tool that could potentially be used for radiation treatment planning. High-risk prostate cancer patients who are scheduled to be treated with intensity-modulated radiotherapy (IMRT) may be eligible to enroll in this study. 99mTc-sulfur nanocolloid, a radiopharmaceutical ("tracer") will be injected by a urologist using transrectal ultrasound guidance (TRUS)at the UCSF Urology Clinic. Participants will then undergo SPECT/CT imaging at the UCSF Nuclear Medicine Clinic. This study will evaluate the feasibility of transporting patients to the Nuclear Medicine Clinic for imaging within 1-3 hours after administration of 99mTc-sulfur nanocolloid.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: SPECT-CT imaging Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Practice Procedure for 99mTc-Sulfur Nanocolloid Lymphatic Drainage Mapping in Prostate Cancer Using SPECT-CT (Single Photon Emission Computed Tomography / Computed Tomography)
Study Start Date : November 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: SPECT-CT imaging
    SPECT/CT for 3-dimensional mapping of 99mTc-sulfur nanocolloid in order to identify personalized lymphatic drainage patterns

Primary Outcome Measures :
  1. Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection [ Time Frame: 1 day ]
    Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.

Secondary Outcome Measures :
  1. Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans [ Time Frame: 1 day ]
    There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008969

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Youngho Seo, PhD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01008969     History of Changes
Other Study ID Numbers: CC085513, H46038-33934
First Posted: November 6, 2009    Key Record Dates
Results First Posted: February 2, 2012
Last Update Posted: February 2, 2012
Last Verified: December 2011

Keywords provided by University of California, San Francisco:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases