Using 68Ga-DOTA-TATE PET/CT imaging for neuroendocrine tumors
Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management
This study is testing a new imaging tool called 68Ga-DOTA-TATE to see if it can better diagnose neuroendocrine tumors compared to the older method.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT04847505 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the PET radiotracer 68Ga-DOTA-TATE for diagnosing neuroendocrine tumors (NETs). It is a pragmatic, single-center, prospective, non-randomized, open-label study conducted across Canada. The goal is to establish 68Ga-DOTA-TATE as a standard diagnostic tool, building on previous studies that have shown its superiority over the former standard, Octreoscan. By gathering additional data, the trial aims to support the routine use of this imaging technique in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected or confirmed neuroendocrine tumors that express somatostatin receptors.
Not a fit: Patients who have had a severe allergic reaction to DOTA-TATE or somatostatin analogs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and patient outcomes for those with neuroendocrine tumors.
How similar studies have performed: Previous studies have demonstrated the effectiveness of 68Ga-DOTA-TATE, indicating that this approach is supported by prior successful research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec and 1 other locations
- Centre Intégré Universitaire de Santé et des Services Sociaux du Centre de l'Ouest de Montréal - Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- Chus — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Éric E Turcotte, MD — Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study coordinator: Stéphanie Dubreuil
- Email: Stephanie.Dubreuil2@usherbrooke.ca
- Phone: 819-346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.