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
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Procedure: F-18-F-DOPA||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|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|
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.
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
- 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.
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
|United States, New York|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|Principal Investigator:||Josephine Rini, MD||North Shore University Hospital|