Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00591643

Purpose

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	Intervention
Adrenal Tumors Adrenal Malignancies Abnormal Hormonal Secretions Electrolytes Abnormalities	Other: Imaging, Adrenal acans

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)

Resource links provided by NLM:

MedlinePlus related topics: Adrenal Gland Cancer Cancer Nuclear Scans

Drug Information available for: Epinephrine bitartrate Epinephrine

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	July 1977
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

n/a

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591643

Contacts

Contact: Neeta Pandit-Taskar, MD

212-639-3046

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Neeta Pandit-Taskar, MD 212-639-3046

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Neeta Pandit-Taskar, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Neeta Pandit-Taskar, MD )
Study ID Numbers:	77-030
Study First Received:	December 26, 2007
Last Updated:	December 22, 2009
ClinicalTrials.gov Identifier:	NCT00591643 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

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:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenal Gland Diseases
Adrenergic Agonists
Neoplasms by Site
Therapeutic Uses
Vasoconstrictor Agents
Epinephrine
Congenital Abnormalities
Endocrine Gland Neoplasms

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Sympathomimetics
Endocrine System Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Pharmacologic Actions
Neoplasms
Mydriatics
Adrenal Gland Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010