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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00875407
First received: April 1, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Chromaffin-tissue Derived Tumors
Other: Scintigraphy in 123I-IBZM

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875407

Locations
France
Assistance Publique-Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: DAVID TAIEB Assistance Publique Hopitaux De Marseille
  More Information

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00875407     History of Changes
Other Study ID Numbers: 2008/09, 2008-A007932-52
Study First Received: April 1, 2009
Last Updated: February 24, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
3-iodo-2-hydroxy-6-methoxy-N-((1-ethyl-2-pyrrolidinyl)methyl)benzamide
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014