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
Jonsson Comprehensive Cancer Center
30 participants
Apr 27, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria2
- Patients who started any PCa treatment between study enrollment and surgery
- Technically inaccessible nodal location
Interventions
Given via IV injection
Undergo SPECT/CT
Undergo SPECT/CT
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04857502