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

April 1, 2009
February 24, 2014
February 2009
July 2012   (final data collection date for primary outcome measure)
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 ]
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. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00875407 on ClinicalTrials.gov Archive Site
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Feasibility of 123I-IBZM Scintigraphy (a D2 Agonist) in Patients With Pheochromocytoma (PHEO) and/or Paraganglioma (PGL) : Study Pilot
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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.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chromaffin-tissue Derived Tumors
Other: Scintigraphy in 123I-IBZM
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00875407
2008/09, 2008-A007932-52
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: DAVID TAIEB Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP