Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
Primary Purpose
Adrenal Tumors, Adrenal Malignancies, Abnormal Hormonal Secretions
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Imaging, Adrenal acans
(NP-59)
Sponsored by
About this trial
This is an interventional diagnostic trial for Adrenal Tumors focused on measuring Adrenal tumors, Adrenal malignancies, abnormal hormonal secretions, electrolytes abnormalities, Imaging, Scanning, tumor localization
Eligibility Criteria
Inclusion Criteria:
- Patient with clinical and laboratory suspicions of hypersecretion of adrenal cortical hormones
Exclusion Criteria:
- n/a
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaging, Adrenal acans & Radiation
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00591643
First Posted
December 26, 2007
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00591643
Brief Title
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
Official Title
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 1977 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
Detailed Description
To investigate the feasibility of using NP-59 to localize adrenal tumors and assess their functions under the influence of pharmacological manipulations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Tumors, Adrenal Malignancies, Abnormal Hormonal Secretions, Electrolytes Abnormalities
Keywords
Adrenal tumors, Adrenal malignancies, abnormal hormonal secretions, electrolytes abnormalities, Imaging, Scanning, tumor localization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaging, Adrenal acans & Radiation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Imaging, Adrenal acans
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
(NP-59)
Intervention Description
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with clinical and laboratory suspicions of hypersecretion of adrenal cortical hormones
Exclusion Criteria:
n/a
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Pandit-Taskar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering web site
Learn more about this trial
Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59)
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