This project aims to monitor the innocuity/safety profile of cyclotron-produced \[68Ga\]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for \[68Ga\]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA.
This study also aims to instigate the use of \[68Ga\]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.
Clinical requisition for a 68Ga-PSMA-617 PET/CT signed by a referring doctor;
Patients with suspected, proven or prior tumor expressing PSMA;
Informed consent by patient.
Patient refusal to participate;
Prior severe anaphylactic reaction to 68Ga-PSMA-617 .
Study will recruit all eligible patients referred to our center for PET/CT imaging with \[68Ga\]-PSMA-617 for 5 years.
Cohort
Prospective
[68Ga]-PSMA-617
Diagnostic testThe intervention consists of an intravenous injection of the radiopharmaceutical \[68Ga\]-PSMA-617 and a physiological saline flush, followed 60-90 minutes later by a PET/CT image acquisition.
Incidence of treatment-emergent adverse events (safety and tolerability) of 68Ga-PSMA-617
Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan. Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.
Generate clinical information on the impact of [68Ga]-PSMA-617 for cancer patient management
PSMA-PET is routinely used to assess and follow-up prostate cancers with unprecedented precision. Recent reports found that most solid cancers are also susceptible to be detected and managed with this modality. This trial offers the opportunity to evaluate the impact of this state-of-the-art diagnostic procedure on the management of eligible cancers patients on a large, nation-wide cohort.
Instigate the routine standard-of-care use of [68Ga]-PSMA-617 for eligible cancer patients
Clinical and scientific evidences hinted that \[68Ga\]-PSMA-617 might be a complementary, even superior diagnostic tool than the current standard-of-care FDG-PET/CT for solid tumors. As such, this trial aims to implement \[68Ga\]-PSMA-617 as the new standard-of-care for precision diagnostic of NETs.
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