An interventional study of F-18-F-DOPA in Neuroendocrine Tumors, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 23 Years to 81 Years. Per ClinicalTrials.gov, last updated 2015-09-03.
Sponsored by Northwell Health · Not applicable, Interventional, and Diagnostic
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.
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.
682 studies on the registry are indexed under Neuroendocrine Tumors; 164 are open to participants now.
This study's enrollment of 22 is below the median of 42 across 470 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.
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23 years of age and older
Less than 23 years of age
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
Also known as: F-18 fluorodopa
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.
Time frame: Mean duration 49 months
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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