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

NCT ID: NCT02539433

Last Updated: 2015-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2015-05-31

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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

F-18-F-DOPA i.v.

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.

Group Type: EXPERIMENTAL

F-18-F-DOPA

Intervention Type: PROCEDURE

F-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection

Interventions

F-18-F-DOPA

F-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection

Intervention Type: PROCEDURE

Other Intervention Names

F-18 fluorodopa

Eligibility Criteria

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Josephine Rini

Physician, North Shore-LIJ Center for Advanced Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josephine Rini, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital

Locations

North Shore University Hospital

Manhasset, New York, United States

Countries

United States

References

Neuroendocrinology 2006;83:27-64 DOI: 10.1159/000093339 Published online: May 15, 2006 3rd Annual ENETS Conference March 22-24, 2006, Prague, Czech Republic. Imaging of Neuroendocrine Tumors Zanzi I., Warner R.R.P., Babchyck B., Studentsova Y., Bjelke D., Belakhlef A., Margouleff D., Chaly T. North Shore University Hospital, Manhasset, New York University School of Medicine, New York, N.Y., USA

Reference Type: RESULT

Other Identifiers

IRB #03-117

Identifier Type: -

Identifier Source: org_study_id