99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorJonsson Comprehensive Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients who started any PCa treatment between study enrollment and surgery
Technically inaccessible nodal location
Trial design
Design model
Single group
Treatments tested in this trial
99mTc-based PSMA Imaging and Surgery Agent
DrugGiven via IV injection
Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Diagnostic (99mTc-PSMA-I&S, SPECT/CT)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 frame
time from injection to imaging (range: 1-46 hours)Secondary outcomes
1
99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score)
Time frame
time from injection to imaging (range: 1-46 hours)2
The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function
Time frame
time from injection to imaging (range: 1-46 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov