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

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ClinicalTrials.gov Identifier: NCT00591643
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adrenal Tumors Adrenal Malignancies Abnormal Hormonal Secretions Electrolytes Abnormalities Procedure: Imaging, Adrenal acans Radiation: (NP-59) Phase 1

Detailed Description:
To investigate the feasibility of using NP-59 to localize adrenal tumors and assess their functions under the influence of pharmacological manipulations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
Study Start Date : July 1977
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011


Arm Intervention/treatment
Experimental: Imaging, Adrenal acans & Radiation Procedure: 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.

Radiation: (NP-59)
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.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591643


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00591643     History of Changes
Other Study ID Numbers: 77-030
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
Adrenal tumors
Adrenal malignancies
abnormal hormonal secretions
electrolytes abnormalities
Imaging
Scanning
tumor localization

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Adrenal Gland Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Neoplasms
Congenital Abnormalities
Endocrine Gland Neoplasms
Neoplasms by Site
Endocrine System Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents