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| Tracking Information | |||||
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| First Received Date ICMJE | December 26, 2007 | ||||
| Last Updated Date | June 19, 2009 | ||||
| Start Date ICMJE | July 1977 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00591643 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) | ||||
| Official Title ICMJE | Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) | ||||
| 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. |
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| Detailed Description | To investigate the feasibility of using NP-59 to localize adrenal tumors and assess their functions under the influence of pharmacological manipulations. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Other: Imaging, Adrenal acans | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00591643 | ||||
| Responsible Party | Neeta Pandit-Taskar, MD, Memorial Sloan-Kettering Cancer Center | ||||
| Study ID Numbers ICMJE | 77-030 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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