SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Michigan Rogel Cancer Center
About this trial
This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* 177Lu-617 PSMA treatment scheduled for mCRPC
Clinically stable as determined by the nuclear medicine clinicians
Male
≥ 18 years of age
Disqualifiers
Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
Trial population
Patients with mCRPC undergoing 177Lu-PSMA-617 treatment at the University of Michigan
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Response and toxicity following 177Lu-RLT
Association between absorbed dose and effect (response/toxicity) following 177Lu-RLT
Time frame
Up to 4 yearsSecondary outcomes
1
Build and test models
Build and test models for predicting therapy delivered absorbed dose from pre-therapy PET imaging/non-imaging biomarkers.
Time frame
Up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan Rogel Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov