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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02810600

Acronym

PET/Ga68

Enrollment

2120

Registered

2016-06-23

Start date

2016-06-08

Completion date

2020-05-29

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

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.

Interventions

OTHERGallium-68 DOTA TATE PET scan

One PET/CT scan using Gallium-68 DOTA TATE

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Record all adverse events	June 2016-June 2018

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026