Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)

Not Applicable

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Procedure: F-18-F-DOPA

• Registration Number: NCT02539433
• Lead Sponsor: Northwell Health

Brief Summary

Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a similar protocol as they had used for PET (Positron emission tomography) or FDG (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation Safety Committee in 1989 and 1994 for the study of neurological diseases and used uneventfully.

Detailed Description

Background: Pre surgical conventional imaging of neuroendocrine tumors (NETs) with CT, MRI, In-111 octreotide or 1-123-MIBG (metaiodobenzylguanidine) scintigraphy has limitations. This pilot study tried to improve the localization of these tumors with F-18-F-DOPA PET scanning.

Methods: The investigators studied 22 patients, the majority referred with clinical diagnosis of carcinoid (9) or NETs (9) and a few with pheochromocytoma/paraganglioma (3). Carbidopa was administered prior to the F-DOPA injection in 12 patients. Comparison was made with prior conventional imaging. The F-DOPA findings, read blindly to the findings of other modalities, were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up of mean duration of 49 months (for 20 patients). Two subjects were lost to follow-up.

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-06-04
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study First Posted: 2015-09-03
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 23 years of age and older
  • Appropriate diagnosis by referring physician

Exclusion Criteria

• Less than 23 years of age
  • Greater than 81 years of age
  • Pregnancy
  • Lactation
  • Prior history of radiation treatment
  • Chemotherapy or anti-tuberculosis medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F-18-F-DOPA i.v.	F-18-F-DOPA	F-18-F-DOPA i.v. one injection of a dose of up to 8.5 mCi (millicurie). Standard PET scanning started 60-90 minutes post injection.

Primary Outcome Measures

Name	Time	Method
Imaging of Neuroendocrine Tumors	Mean duration 49 months	The investigators expect F-18-DOPA to be taken substantially by carcinoid or pheochromocytoma. The outcome for the study is to identify the location of the neoplasm(s) and compare this data with the clinical OctreoScan or I-131 MIBG performed. If the PET/DOPA scan shows different information than the clinical scan that will be communicated to the referring physician. Efforts will be made to collect information regarding the clinical outcome of the patient, further anatomical imaging and/or surgical pathology results.

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States