Clinical Trial: 18F-FDOPA PET in Neuroendocrine Tumours

Study Status: Available
Recruit Status: Available
Study Type: Expanded Access

Official Title: [18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) Positron Emission Tomography (PET) in Neuroendocrine Tumours

Brief Summary:

Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the gastroenteropancreatic tract. They are usually slow growing, have low malignant potential, and often go unnoticed until they become metastatic. The correct treatment approach is dependent on the extent of the disease, however surgical approaches and systemic therapy can be curative.

Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer 18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising non-invasive technique to help localizing NETs and guide their treatment.


Detailed Summary:

Purpose/Objective:

The purpose of this study is to provide access to 18F-6-L fluorodihydroxyphenylalanine (18F-FDOPA) positron emission tomography and computed tomography (PET/CT) imaging to patients with neuroendocrine tumours (NET) and to collect additional data about the effectiveness of 18F-DOPA PET/CT in this patient population.

Hypothesis:

  1. The overall accuracy of 18F-FDOPA PET/CT is superior to conventional imaging techniques for the detection of neuroendocrine tumours.
  2. The sensitivity of 18F-FDOPA PET/CT is superior to conventional imaging techniques for the detection of neuroendocrine tumours.

Justification:

Treatment of NET's depends on the extent of disease and rate of tumour progression. Accurate staging is critical to establish the prognosis of the disease, to guide potentially curative surgical approaches and to assist in therapeutic decision making between surgery, embolization techniques and systemic therapy. Standard radiologic and nuclear medicine techniques all have significant limitations in terms of their ability to detect these lesions and to evaluate response to treatment. The widely used PET tracer 18F-Fluorodeoxyglucose (18-FDG) is of limited value in NET's due to its non-specific uptake and the relatively low mitotic rate often seen in these tumours.

Combined PET/CTutilizing 18F-FDOPA has been investigated as a potentially sensitive and specific staging and localization technique for NETs. Expression of tumour-specific catecholamine transport and storage mechanisms by NET cells is the basis of 18F-DOPA PET imaging. Cellular uptak
Sponsor: British Columbia Cancer Agency

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: British Columbia Cancer Agency

Dates:
Date Received: April 27, 2015
Date Started: October 2012
Date Completion: August 2018
Last Updated: December 28, 2016
Last Verified: December 2016