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

Neuroendocrine Tumors Clinical Trial

— PET/Ga68  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810600
• Other study ID #: Gallium DOTATATE/PET scan
• Status: Completed
• Start date: June 8, 2016
• Est. completion date: May 29, 2020

Study information

• Verified date: May 2021
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2120
• Est. completion date: May 29, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Other:
• Gallium-68 DOTA TATE PET scan
One PET/CT scan using Gallium-68 DOTA TATE

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Record all adverse events		June 2016-June 2018