Clinical trial
99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
Name
20-002256
Description
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.
Trial arms
Trial start
2021-04-27
Estimated PCD
2024-06-01
Trial end
2025-06-01
Status
Recruiting
Phase
Early phase I
Treatment
99mTc-based PSMA Imaging and Surgery Agent
Given via IV injection
Arms:
Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
Computed Tomography
Undergo SPECT/CT
Arms:
Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
Other names:
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Arms:
Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
Other names:
Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Size
30
Primary endpoint
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)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-12-12
1 organization
1 product
1 indication
Organization
Jonsson Comprehensive Cancer CenterIndication
Prostate Cancer