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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
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 26, 2007
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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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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