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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:
ClinicalTrials.gov Identifier:
NCT00875407
First Posted: April 3, 2009
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
April 1, 2009
April 3, 2009
February 25, 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 ]
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.
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: None (Open Label)
Primary Purpose: Treatment
Chromaffin-tissue Derived Tumors
Other: Scintigraphy in 123I-IBZM
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Saveanu A, Sebag F, Guillet B, Archange C, Essamet W, Barlier A, Palazzo FF, Taïeb D. Targeting dopamine receptors subtype 2 (D2DR) in pheochromocytomas: head-to-head comparison between in vitro and in vivo findings. J Clin Endocrinol Metab. 2013 Dec;98(12):E1951-5. doi: 10.1210/jc.2013-2269. Epub 2013 Sep 5.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00875407
2008/09
2008-A007932-52
No
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Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
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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