Feasibility of 123I-IBZM Scintigraphy (a D2 Agonist) in Patients With Pheochromocytoma (PHEO) and/or Paraganglioma (PGL) : Study Pilot

Not Applicable

Completed

• Conditions: Chromaffin-tissue Derived Tumors

• Registration Number: NCT00875407
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.

Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age + 18 years. The women in ages to procreate have to have an effective contraception or a negative pregnancy test (in the absence of effective contraception) Having a radiological and functional imaging (balance sheet(assessment) pré--IBZM) considered adapted and complete for the pathology.
• Having a phéochromocytome or a paragangliome proving a surgical operation in view of the data of the balance sheet(assessment) pré--IBZM.
• With or without allergy in the iodine.

Exclusion Criteria

• NEM2A or 2B.
• Malignant Forms which do not recover from an even partial, surgical gesture(movement).
• Pregnant Women or in the course of feeding.
• Women in age to procreate without effective contraception, with positive pregnancy test.
• Renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.	3 years

Trial Locations

Locations (1)

Assistance Publique-Hopitaux de Marseille; 🇫🇷 Marseille, France