Completed

The Clinical Impact of 68Ga-DOTATATE PET in the Management of Patients With Neuroendocrine Tumors

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What is being tested

68Ga -DOTATATE PET scans

Diagnostic Test
Who is being recruted

Neoplasms+3

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Over 14 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2019
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2019

Actual date on which the first participant was enrolled.

When patients are suspected of having neuroendocrine tumours, they will usually undergo various imaging scans such as computed tomography (CT) scan and magnetic resonance imaging (MRI), and octreotide scintigraphy (octreoscan) to try to identify the primary tumour. During the patients' course of disease, they will continue to have various CT, MRI, and/or octreoscans. Sometimes, despite using scans, laboratory tests, and examination, it is still difficult to properly diagnose neuroendocrine tumours. Doctors have found that most neuroendocrine tumours make too much of a hormone called somatostatin on their cell surface. Because of this doctors have been using positron emission tomography (PET) scans using a special contrast dye called 68Ga-DOTATATE in hopes of better diagnosing and managing neuroendocrine tumours. 68Ga-DOTATATE can label the cells that have somatostatin (such as neuroendocrine tumour cells) so that the PET scan can take better pictures and doctors can better diagnose and manage the disease. However, despite 68Ga-DOTATATE PET scans showing promise, it is still not widely accessible. Because of this, researchers are creating a registry for patients who may need 68Ga-DOTATATE PET scans to: * Identify their primary tumour where the doctor suspects is a neuroendocrine tumour * Staging of the neuroendocrine tumour * Restage the tumour prior to surgery/radiotherapy or help to assess the tumour where standard scans such as CTs, MRIs, or octreoscans are not properly showing your tumours despite other clinical or laboratory tests showing that your disease has progressed * For other issues when confirmation of site of disease and/or disease extent may impact clinical management of the neuroendocrine tumour. This registry help the participant's treating physician to obtain approval for the participant to undergo 68Ga-DOTATATE PET scans for their neuroendocrine tumour.

Official TitleThe Clinical Impact of 68Ga-DOTATATE PET in the Management of Patients With Neuroendocrine Tumors
NCT03873870
Principal SponsorUniversity Health Network, Toronto
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

1916 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeuroectodermal TumorsNeuroendocrine Tumors

Criteria

Inclusion Criteria: * Able to undergo PET/CT without sedation * Any of the following indications: * Group A. Identification of primary tumor: For the initial diagnosis of patients with clinical (e.g., signs, symptoms) and/or biochemical (e.g., tumor markers) suspicion of neuroendocrine tumours (NETs) but for whom conventional imaging is negative or equivocal or for whom biopsy is not easily obtained. * Group B. Staging: For the staging of patients with localized primary NETs and/or limited metastasis where definitive surgery is planned. * Group C. Restaging: Restaging of patients with NET where surgery or peptide-receptor radiotherapy (PRRT) is being considered; OR, where conventional imaging is negative or equivocal at time of clinical and/or biochemical progression. * Group D. As a problem-solving tool: As a problem-solving tool in patient with NET when confirmation of site of disease and/or disease extent may impact clinical management. * Approved by a review panel if Group D. Exclusion Criteria: * Inability to provide informed consent. * Contraindication for PET examination as per institutional safety guidelines, including but not limited to pregnancy, or inability to lie still for PET examination. * Need for full sedation to undergo PET/CT scan.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single arm study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Princess Margaret Cancer Centre

Toronto, CanadaOpen Princess Margaret Cancer Centre in Google Maps
CompletedOne Study Center