Skip to main content
OpenTrials
Completed

NCT Number: NCT03873870

68Ga-DOTATATE PET for Management of Neuroendocrine Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga -DOTATATE PET scans

Diagnostic Test

PET scan using 68Ga-DOTATATE contrast

Primary outcomes

  1. 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

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

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.

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

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2019
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.