Actively Recruiting
99mTc-PSMA-I&S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-13
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the biodistribution of a radioactive agent called 99mTc-PSMA-I&S in men with prostate cancer who are undergoing pelvic lymph node dissection. This exploratory, early-phase study aims to understand how this agent spreads in normal and cancerous tissues, helping to detect prostate cancer that has spread to lymph nodes. The study also seeks to find the best timing for using this agent during surgery and to correlate imaging results with tissue analysis when possible. The study involves giving an intravenous dose of 99mTc-PSMA-I&S to participants. The first five patients receive an initial dose followed by five SPECT/CT scans at multiple time points over about two days. These patients then get a second dose before standard surgery. All other participants receive one dose before their scheduled surgery. The imaging uses single-photon emission computed tomography combined with computed tomography (SPECT/CT) to detect cancerous lymph nodes. Participants will undergo several imaging scans to track how the radioactive agent distributes in their bodies over time. Researchers will measure uptake values in tissues and compare these with tissue samples analyzed during surgery. The study will assess the best timing for surgery using this agent based on tumor-to-background uptake ratios. The total participation includes imaging visits and standard care surgery, with follow-up limited to the study procedures and data collection.
CONDITIONS
Brief Title
99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with prostate cancer (primary or recurrent disease)
- Men who have had a 68Ga-PSMA-11 PET/CT for staging or restaging
- Men with evidence of lymph node-positive disease on 68Ga-PSMA-11 PET/CT
- Men scheduled for pelvic lymph node dissection surgery
- Men who can provide oral and written informed consent
- Men who can comply with study procedures
You will not qualify if you...
- Patients who started any prostate cancer treatment between enrollment and surgery
- Technically inaccessible nodal locations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 days for imaging scans after initial dose
Participants receive an intravenous dose of 99mTc-PSMA-I&S followed by multiple SPECT/CT scans to assess biodistribution of the agent in normal and malignant tissues.
Up to 5 imaging visits within 3 to 46 hours post-injection
Duration - Single day for surgery and 99mTc-PSMA-I&S administration
Participants receive a second dose of 99mTc-PSMA-I&S followed by standard of care surgery to remove pelvic lymph nodes. Subsequent participants receive one dose before surgery.
1 surgery visit (in-person)
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
D
Deepu Varughese
A
Ankush Sachdeva
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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