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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

Tracking Information
First Submitted Date  ICMJE June 4, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date September 3, 2015
Study Start Date  ICMJE December 2003
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Official Title  ICMJE Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Procedure: F-18-F-DOPA
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539433
Other Study ID Numbers  ICMJE IRB #03-117
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Josephine Rini, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josephine Rini, MD North Shore University Hospital
PRS Account Northwell Health
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP