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

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ClinicalTrials.gov Identifier: NCT02539433
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Josephine Rini, 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Procedure: F-18-F-DOPA Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Study Start Date : December 2003
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Arm Intervention/treatment
Experimental: 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.
Procedure: 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
Other Name: F-18 fluorodopa




Primary Outcome Measures :
  1. Imaging of Neuroendocrine Tumors [ Time Frame: 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.



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Ages Eligible for Study:   23 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539433


Locations
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United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Josephine Rini, MD North Shore University Hospital

Publications of Results:
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

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Responsible Party: Josephine Rini, Physician, North Shore-LIJ Center for Advanced Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT02539433     History of Changes
Other Study ID Numbers: IRB #03-117
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs