NCT05228106

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2022Jan 2027

Study Start

First participant enrolled

January 21, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

January 27, 2022

Last Update Submit

February 5, 2024

Conditions

Solid Cancers

Keywords

[68Ga]-PSMA-617PET imagingPragmatic studyPSMA-expressing cancers

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Secondary Outcomes (2)

  • Generate clinical information on the impact of [68Ga]-PSMA-617 for cancer patient management

    5 years

  • Instigate the routine standard-of-care use of [68Ga]-PSMA-617 for eligible cancer patients

    5 years

Study Arms (1)

Patients eligible for [68Ga]-PSMA-617-PET

All cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with a \[68Ga\]-PSMA-617 dose calculated depending on the characteristics of the PET tomograph and patient weight (maximum 370 MBq). 60-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.

Diagnostic Test: [68Ga]-PSMA-617

Interventions

[68Ga]-PSMA-617DIAGNOSTIC_TEST

The 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.

Also known as: PSMA-PET
Patients eligible for [68Ga]-PSMA-617-PET

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study will recruit all eligible patients referred to our center for PET/CT imaging with \[68Ga\]-PSMA-617 for 5 years.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient refusal to participate;
  • Prior severe anaphylactic reaction to 68Ga-PSMA-617 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUS

Sherbrooke, Quebec, J1H5N4, Canada

RECRUITING

Study Officials

  • Éric E Turcotte, MD

    Université de Sherbrooke, Centre de Recherche du CHUS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Dubreuil

CONTACT

819-346-1110Stephanie.Dubreuil2@usherbrooke.ca

Michel Paquette, PhD

CONTACT

819-346-1110michel.paquette@usherbrooke.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 8, 2022

Study Start

January 21, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CA(1)