NCT02810600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,120

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

3.6 years

First QC Date

June 16, 2016

Last Update Submit

May 17, 2021

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • Record all adverse events

    June 2016-June 2018

Interventions

Gallium-68 DOTA TATE PET scanOTHER

One PET/CT scan using Gallium-68 DOTA TATE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or diagnosed with tumors expressing somatostatin receptors

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 23, 2016

Study Start

June 8, 2016

Primary Completion

January 1, 2020

Study Completion

May 29, 2020

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)