Neuroendocrine Tumors Clinical Trial
Official title:
The Clinical Impact of 68Ga-DOTATATE PET in the Management of Patients With Neuroendocrine Tumors
Verified date | January 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1916 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | NA. One time visit for 68Ga-DOTATATE PET scan | |
Secondary | 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. | NA. One time visit for 68Ga-DOTATATE PET scan |
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