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

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

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

Conditions
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Adrenal Tumors, Adrenal Malignancies, Abnormal Hormonal Secretions, Electrolytes Abnormalities

Intervention / Treatment
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* Procedure: Imaging, Adrenal acans
* Radiation: (NP-59)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with clinical and laboratory suspicions of hypersecretion of adrenal cortical hormones Exclusion Criteria: n/a
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging, Adrenal acans & Radiation<br> | Procedure: Imaging, Adrenal acans<br>* 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.<br>Radiation: (NP-59)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the feasibility of using NP-59 to localize adrenal tumors and assess their functions under the influence of pharmacological manipulations. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenal tumors, Adrenal malignancies, abnormal hormonal secretions, electrolytes abnormalities, Imaging, Scanning, tumor localization