Clinical trial · Interventional
Feasibility of Using SPECT/CT Imaging to Map Lymphatic Drainage Patterns in Prostate Cancer Patients
Practice Procedure for 99mTc-Sulfur Nanocolloid Lymphatic Drainage Mapping in Prostate Cancer Using SPECT-CT (Single Photon Emission Computed Tomography / Computed Tomography)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPECT-CT imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection
- timeFrame
- 1 day
- 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.
Secondary outcomes (1)
- measure
- Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans
- timeFrame
- 1 day
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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