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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-08

Study Completion Date

2020-05-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gallium-68 DOTA TATE PET scan

One PET/CT scan using Gallium-68 DOTA TATE

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No