Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors (PET/Ga68)

May 17, 2021 updated by: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Phase II 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected or diagnosed with tumors expressing somatostatin receptors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Record all adverse events
Time Frame: June 2016-June 2018
June 2016-June 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gallium DOTATATE/PET scan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Tumors

Clinical Trials on Gallium-68 DOTA TATE PET scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe