CClinicalTrials.gg
Sign In
CompletedNCT03873870Updated Jan 17, 2024

68Ga-DOTATATE PET for Management of Neuroendocrine Tumors

An interventional study of 68Ga -DOTATATE PET scans in Neuroendocrine Tumors, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-01-17.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,916
Allocation
Not applicable
Ages
14 Years and older
Sex
All
01

Study summary

This is a research study to collect information regarding usefulness of positron emission tomography (PET) scans using a special dye called 68Ga-DOTATATE for patients with neuroendocrine tumours by determining the number of of patients whose clinical management was changed as a result of the scans.

Read the detailed description

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.

02

Conditions studied

  • Neuroendocrine Tumors

Browse trials for

Keywords

  • PET scans
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 1,916 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,916 participants (actual)

Study arms

  • Experimental
    68Ga -DOTATATE PET scan

    Single arm study.

    Diagnostic Test: 68Ga -DOTATATE PET scans

Interventions

  • Diagnostic test68Ga -DOTATATE PET scans

    PET scan using 68Ga-DOTATATE contrast

06

What researchers measure

Primary outcomes

  1. Detection of additional disease and/or change in extent of disease after 68Ga-DOTATATE PET

    Detection of additional disease and/or change in extent of disease after 68Ga-DOTATATE PET

    Time frame: NA. One time visit for 68Ga-DOTATATE PET scan

Secondary outcomes

  1. To determine the proportion of patients with NET (or clinical suspicion of NET) in whom intended clinical management prior to PET is changed after 68Ga-DOTATATE PET.

    To determine the proportion of patients with NET (or clinical suspicion of NET) in whom intended clinical management prior to PET is changed after 68Ga-DOTATATE PET.

    Time frame: NA. One time visit for 68Ga-DOTATATE PET scan

07

Study locations

1 site
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03873870
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Mar 14, 2019
Start date
Mar 28, 2019
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Jan 17, 2024

Study contacts

Ur Metser, M.D.
principal investigator · Princess Margaret Cancer Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neuroendocrine Tumors→

Other studies from this sponsor

University Health Network, Toronto

Start the discussion