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

NCT00591643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2015-12-28

No results posted yet for this study

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.

Conditions

  • Adrenal Tumors
  • Adrenal Malignancies
  • Abnormal Hormonal Secretions
  • Electrolytes Abnormalities

Interventions

PROCEDURE

Imaging, Adrenal acans

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.

RADIATION

(NP-59)

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.

Sponsors & Collaborators

Principal Investigators

  • Neeta Pandit-Taskar, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1977-07-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00591643 on ClinicalTrials.gov