Health TrialsbyHealthPanel

68Ga-DOTA-TATE PET/CT Imaging in NETs

ConditionNeuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCentre de recherche du Centre hospitalier universitaire de Sherbrooke

About this trial

This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor

Patients with suspected or proven tumors expressing somatostatin receptors

Informed consent by patient (or parents if patient is less than 18 years of age)

Disqualifiers

*Pregnancy (not an absolute exclusion). See below*.

Patient refusal to participate.

Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.

Severe medical condition involving the life of the pregnant woman and/or the fetus;

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-DOTA-TATE

    Diagnostic test

    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.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Neuroendocrine cancer patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety profile of 68Ga-DOTA-TATE

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.

Time frame
5 years

Secondary outcomes

1

Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management

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.

Time frame
5 years
2

Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients

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.

Time frame
5 years

Other outcomes

Sponsors and contacts

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Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead sponsor

Université de Sherbrooke

Collaborator

Jewish General Hospital

Collaborator

Source ClinicalTrials.gov
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