68Ga-DOTATATE PET for Management of Neuroendocrine Tumors
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
68Ga -DOTATATE PET scans
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring PET scans
Eligibility Criteria
Inclusion Criteria:
- Able to undergo PET/CT without sedation
Any of the following indications:
- 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.
- For the staging of patients with localized primary NETs and/or limited metastasis where definitive surgery is planned.
- 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.
- 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
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.
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga -DOTATATE PET scan
Arm Description
Single arm study.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03873870
First Posted
March 12, 2019
Last Updated
June 9, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03873870
Brief Title
68Ga-DOTATATE PET for Management of Neuroendocrine Tumors
Official Title
The Clinical Impact of 68Ga-DOTATATE PET in the Management of Patients With Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
PET scans
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1916 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68Ga -DOTATATE PET scan
Arm Type
Experimental
Arm Description
Single arm study.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga -DOTATATE PET scans
Intervention Description
PET scan using 68Ga-DOTATATE contrast
Primary Outcome Measure Information:
Title
Detection of additional disease and/or change in extent of disease after 68Ga-DOTATATE PET
Description
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 Outcome Measure Information:
Title
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.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ur Metser, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
68Ga-DOTATATE PET for Management of Neuroendocrine Tumors
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