Clinical Trial · NCT02810600

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

Overview

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.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

ClinicalTrials.gov

NCT02810600

Drug / Compound

DOTA-TATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Patients with suspected or proven tumors expressing Somatostatin receptors

Exclusion

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