NCT02539433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
Last Updated

September 3, 2015

Status Verified

August 1, 2015

Enrollment Period

11.4 years

First QC Date

June 4, 2015

Last Update Submit

August 31, 2015

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • 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.

    Mean duration 49 months

Study Arms (1)

F-18-F-DOPA i.v.

EXPERIMENTAL

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

Interventions

F-18-F-DOPAPROCEDURE

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
F-18-F-DOPA i.v.

Eligibility Criteria

Age23 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Appropriate diagnosis by referring physician

You may not qualify if:

  • Less than 23 years of age
  • Greater than 81 years of age
  • Pregnancy
  • Lactation
  • Prior history of radiation treatment
  • Chemotherapy or anti-tuberculosis medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Josephine Rini, MD

    North Shore University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, North Shore-LIJ Center for Advanced Medicine

Study Record Dates

First Submitted

June 4, 2015

First Posted

September 3, 2015

Study Start

December 1, 2003

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-08

Locations

US(1)