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Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00591643
First received: December 26, 2007
Last updated: March 10, 2011
Last verified: March 2011
History of Changes

December 26, 2007
March 10, 2011
July 1977
March 2011   (final data collection date for primary outcome measure)
To investigate the feasibility of using NP-59 to localize adrenal tumors and assess their functions under the influence of pharmacological manipulations. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00591643 on ClinicalTrials.gov Archive Site
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Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)

The purpose of this study is to find out if your adrenal glands are normal or abnormal. This can be determined by whether or not your adrenal gland concentrates more of a labeled building block of adrenal hormone, norcholesterol. This labeled material had been used as an investigative diagnostic tool for imaging adrenal glands for many years with success in our hands. This is a diagnostic procedure. CT, MRI and Ultrasound can determine the size and presence or absence of tumor but cannot assess the function of the adrenal glands. To determine hormone concentrations from blood samples would involve more invasive catherization.

To investigate the feasibility of using NP-59 to localize adrenal tumors and assess their functions under the influence of pharmacological manipulations.
Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Adrenal Gland Neoplasms
  • Adrenal Malignancies
  • Abnormal Hormonal Secretions
  • Electrolytes Abnormalities
Other: Imaging, Adrenal acans
The patient will be given 5 drops of saturated solution of potassium iodide daily for 2 days prior to the study and will continue for 5 to 7 days later to minimize the radiation dose to the thyroid gland. One to 2 mCi of I 131 1,6-beta-iodomethyl-19-norcholesterol (NP-59) in 10% ethanol, 0.23% polysorbate 80 and 0.9% NaCl will be given intravenously slowly over 1-5 minutes. Anterior and posterior images of the adrenal area will be obtained 72 and 96 hours later. Additional images will be made if indicated. Each image would require 30 minutes carried out in the nuclear medicine laboratory. To verify the exact location of the adrenal glands, renal scan with 99m Tc DTPA or Mag 3 (routine nuclear medicine radiopharmaceuticals) will also be obtained whenever indicated. In some patients, dexamethasone suppression will be carried out to improve the specificity of NP 59 diagnosis for autonomous hormonal secretions by the adrenal tumors.
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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
93
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with clinical and laboratory suspicions of hypersecretion of adrenal cortical hormones

Exclusion Criteria:

  • n/a
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591643
77-030
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Neeta Pandit-Taskar, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2011

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