Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors
Completed
- Conditions
- Neuroendocrine Tumors
- Registration Number
- NCT02810600
- Lead Sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Brief Summary
Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE injection in patients with suspected or diagnosed with tumors expressing somatostatin receptors. Each included patient will receive an administered dose of 50 mcg or less of the peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.
The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2120
Inclusion Criteria
- Patients with suspected or proven tumors expressing Somatostatin receptors
- Informed consent by patient (or parents if patient is less than 18 years of age)
Exclusion Criteria
- Pregnancy (confirmed). In the case of a diagnostic procedure in a patient who is or may be pregnant, a clinical decision is necessary considering the benefits against the possible harm of carrying out any procedure.
- Patient refusal to participate.
- Impossibility to tolerate a decubitus position for 25 minutes
- Prior allergic reaction to DOTA-TATE or somatostatin analogs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Record all adverse events June 2016-June 2018
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada