Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F-18-F-DOPA
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors
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.
Sites / Locations
- North Shore University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F-18-F-DOPA i.v.
Arm Description
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.
Outcomes
Primary Outcome Measures
Imaging of Neuroendocrine Tumors
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02539433
Brief Title
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Official Title
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F-18-F-DOPA i.v.
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
F-18-F-DOPA
Other Intervention Name(s)
F-18 fluorodopa
Intervention Description
F-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection
Primary Outcome Measure Information:
Title
Imaging of Neuroendocrine Tumors
Description
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.
Time Frame
Mean duration 49 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josephine Rini, MD
Organizational Affiliation
North Shore University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
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