- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00591643
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
December 23, 2015 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
93
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient with clinical and laboratory suspicions of hypersecretion of adrenal cortical hormones
Exclusion Criteria:
- n/a
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaging, Adrenal acans & Radiation
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neeta Pandit-Taskar, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1977
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
First Posted (Estimate)
January 11, 2008
Study Record Updates
Last Update Posted (Estimate)
December 28, 2015
Last Update Submitted That Met QC Criteria
December 23, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Adrenal Gland Diseases
- Neoplasms
- Congenital Abnormalities
- Adrenal Gland Neoplasms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- 77-030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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