Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors (PET/Ga68)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status: Completed

Conditions: Neuroendocrine Tumors

Treatments: Other: Gallium-68 DOTA TATE PET scan

Study type: Observational

Funder types: Other

Identifiers

NCT02810600

Gallium DOTATATE/PET scan

Details and patient eligibility

About

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.

Enrollment: 2,120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with suspected or proven tumors expressing Somatostatin receptors
2. Informed consent by patient (or parents if patient is less than 18 years of age)

Exclusion criteria

1. 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.
2. Patient refusal to participate.
3. Impossibility to tolerate a decubitus position for 25 minutes
4. Prior allergic reaction to DOTA-TATE or somatostatin analogs