Studying 99mTc-PSMA-I&S in Prostate Cancer

This study is looking at how a special imaging agent, 99mTc-PSMA-I&S, spreads throughout the body in men with prostate cancer. This agent is given through an IV and helps doctors see if prostate cancer has spread to the lymph nodes during surgery. You might be able to join if you are a man with prostate cancer (either new or returning), have had a 68Ga-PSMA-11 PET/CT scan showing lymph nodes are involved, and are scheduled for lymph node removal surgery. The main goal is to understand how much of the 99mTc-PSMA-I&S is found in both healthy and cancerous tissues. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional study with 30 participants. The first 5 participants will receive two doses of 99mTc-PSMA-I&S and undergo multiple SPECT/CT scans, while subsequent participants receive one dose before surgery.
What's involved
You would receive an IV injection of 99mTc-PSMA-I&S and undergo SPECT/CT scans. If you are one of the first 5 participants, you will have 5 scans over 1-46 hours after the first dose, then a second dose before surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures are taken at various times from 1 to 46 hours after injection, which suggests imaging will occur within this timeframe.

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NCT04857502

99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

Recruiting
EARLY_PHASE1All AgesInterventionalBasic science
Jonsson Comprehensive Cancer Center
~30 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:99mTc-based PSMA Imaging and Surgery AgentComputed TomographySingle Photon Emission Computed Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)
Measured over time from injection to imaging (range: 1-46 hours)
Prostate Carcinoma
Recurrent Prostate Carcinoma
1 sites across 1 states
California1
  • Jeremie Calais, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men with PCa (primary or recurrent disease)
Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
Men who are scheduled for pelvic LN dissection (PLND)
Men who can provide oral and written informed consent
Men who can comply with study procedures

Exclusion

Patients who started any PCa treatment between study enrollment and surgery
Technically inaccessible nodal location
  • The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)time from injection to imaging (range: 1-46 hours)