Clinical trial NCT04847505: 68Ga-DOTA-TATE PET/CT Imaging in NETs
Official title: Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Keywords: 68Ga-DOTA-TATE
PET imaging
Pragmatic study
Neuroendocrine tumors (NET)
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Sherbrooke
name: Jewish General Hospital
First posted: 2021-04-19
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: Inclusion Criteria:

1. Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor
2. Patients with suspected or proven tumors expressing somatostatin receptors
3. Informed consent by patient (or parents if patient is less than 18 years of age)

Exclusion Criteria:

1. \*Pregnancy (not an absolute exclusion). See below\*.
2. Patient refusal to participate.
3. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.

   * In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be:

     * Severe medical condition involving the life of the pregnant woman and/or the fetus;
     * Existing treatments that are ineffective or may present toxicity to the woman and/or fetus;
     * High clinical suspicion of a somatostatin receptor overexpressing tumour;
     * Negative, indeterminate or contraindicated first-line imaging tests;
     * Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery;
     * Documented discussion with the treating team and the patient;
     * Patient agrees.

Primary outcomes:
measure: Safety profile of 68Ga-DOTA-TATE
timeFrame: 5 years
Secondary outcomes:
measure: Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management
timeFrame: 5 years
measure: Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Intégré Universitaire de Santé et des Services Sociaux du Centre de l'Ouest de Montréal - Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Éric E Turcotte, MD
role: PRINCIPAL_INVESTIGATOR
References: