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Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160925
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas.

Condition or disease Intervention/treatment Phase
Clinical T1 Renal Mass Other: Preoperative 99mTc-Sestamibi SPECT/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma
Study Start Date : May 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preoperative 99mTc-Sestamibi SPECT/CT Other: Preoperative 99mTc-Sestamibi SPECT/CT



Primary Outcome Measures :
  1. Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection. [ Time Frame: Within 2 weeks of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of a solid enhancing cT1 renal mass detected on cross-sectional imaging
  • Scheduled to undergo surgery with either partial or radical nephrectomy
  • Age ≥18 years

Exclusion Criteria:

  • Pregnancy
  • Evidence of nodal or distant metastases
  • History of other malignancy with concern for renal metastasis
  • Known allergy to technetium or sestamibi

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160925


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Mohamad Allaf, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02160925    
Other Study ID Numbers: IRB00027784
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action