68Ga-DOTA-TATE PET/CT Imaging in NETs
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|ClinicalTrials.gov Identifier: NCT04847505|
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : July 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Diagnostic Test: 68Ga-DOTA-TATE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Neuroendocrine cancer patients, regardless of the primary tumor origin, are eligible. Recruitment is across all Canada but the examination is performed at the primary site of the study. The safety profile of the procedure will be assessed, and integration of 68Ga-DOTA-TATE will be integrated in the routine clinical practice.|
|Masking:||None (Open Label)|
|Official Title:||Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Neuroendocrine cancer patients
All neuroendocrine 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 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 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-DOTA-TATE
The intervention consists of an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE and a physiological saline flush, followed 45-90 minutes later by a PET/CT image acquisition.
Other Name: Netspot
- Safety profile of 68Ga-DOTA-TATE [ Time Frame: 5 years ]
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-DOTA-TATE for NET patient management [ Time Frame: 5 years ]Neuroendocrine tumors (NET) used to be difficult to diagnose early with conventional methods, but with the advent of new-generation Somatostatin Receptor radioligands such as 68Ga-DOTA-TATE precise and early detection is now frequent. This trial offers the opportunity to evaluate the impact of this state-of-the-art diagnostic procedure on the management of NET patients on a large, nation-wide cohort. As such, the research team will monitor the clinical gain of 68Ga-DOTA-TATE on the diagnostic and management of NETs regarding sensitivity, specificity and accuracy compared to previous diagnostic methods.
- Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients [ Time Frame: 5 years ]Clinical and scientific evidences showed that 68Ga-DOTA-TATE is vastly superior as a diagnostic tool than the current standard-of-care Octreoscan. As such, this trial aims to implement 68Ga-DOTA-TATE as the new standard-of-care for precision diagnostic of NETs. In order to do so, health policy agencies (most notably Health Canada) will be notified about the gains (or the flaws if any) of 68Ga-DOTA-TATE over the current standard-of-care (Octreoscan) for the precise diagnostic and follow-up of NETs that will be observed during the present study. The safety profile and diagnostic accuracy assessed in Outcome 1 and 2 will be used to convince the authorities of the net benefit of using this procedure rather than the "old" standard-of-care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847505
|Contact: Stéphanie Dubreuil||819-346-1110 ext 16617||Stephanie.Dubreuil2@usherbrooke.ca|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Stéphanie Dubreuil 819-346-1110 ext 16617 Stephanie.Dubreuil2@Usherbrooke.ca|
|Principal Investigator: Éric Turcotte, MD|
|Principal Investigator:||Éric E Turcotte, MD||Centre de recherche du Centre hospitalier universitaire de Sherbrooke|