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Trial record 7 of 59 for:    somatostatin receptor | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT02810600
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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.


Condition or disease Intervention/treatment
Neuroendocrine Tumors Other: Gallium-68 DOTA TATE PET scan

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Phase II Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors
Actual Study Start Date : June 8, 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2025



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


Primary Outcome Measures :
  1. Record all adverse events [ Time Frame: June 2016-June 2018 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected or diagnosed with tumors expressing somatostatin receptors
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810600


Contacts
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Contact: Helena Senta, PhD 819-346-1110 ext 13660 helena.senta@usherbrooke.ca
Contact: Éric Lavallée, TIM 819-346-1110 ext 12887 eric.lavallee2@usherbrooke.ca

Locations
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Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Eric Turcotte, MD         
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Additional Information:

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Responsible Party: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT02810600     History of Changes
Other Study ID Numbers: Gallium DOTATATE/PET scan
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs