Clinical trial · Interventional
99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
- 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)
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.
Conditions
Conditions (2)
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 Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-based PSMA Imaging and Surgery Agent | Drug | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Single Photon Emission Computed Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
- description
- The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I\&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before standard of care surgery.
- interventionNames
- Drug: 99mTc-based PSMA Imaging and Surgery Agent
- Procedure: Computed Tomography
- Procedure: Single Photon Emission Computed Tomography
Primary outcomes (1)
- measure
- 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)
- timeFrame
- time from injection to imaging (range: 1-46 hours)
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Patients who started any PCa treatment between study enrollment and surgery * Technically inaccessible nodal location
References
Publications (0)
Data not yet available