68Ga-DOTATATE PET for Management of Neuroendocrine Tumors

NCT03873870 | Completed

• 2 other identifiers: 19-5034PET NET Registry
• Study Type: interventional
• Target: 1,916
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Keywords

PET scans

Outcome Measures

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

  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.

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

Study Arms (1)

68Ga -DOTATATE PET scan

EXPERIMENTAL

Single arm study.

Diagnostic Test: 68Ga -DOTATATE PET scans

Interventions

68Ga -DOTATATE PET scans DIAGNOSTIC_TEST

PET scan using 68Ga-DOTATATE contrast

68Ga -DOTATATE PET scan

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Ur Metser, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: March 28, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CA (1)