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OpenTrials
Completed

NCT Number: NCT02810600

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

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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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gallium-68 DOTA TATE PET scan

Other

One PET/CT scan using Gallium-68 DOTA TATE

Primary outcomes

  1. Record all adverse events

    Time frame: June 2016-June 2018

Sponsors and collaborators

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Other

Registry information

Official study title

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

Acronym: PET/Ga68

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2016
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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