- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160925
Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma
July 29, 2019 updated by: Johns Hopkins University
The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Preoperative 99mTc-Sestamibi SPECT/CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection.
Time Frame: Within 2 weeks of surgery
|
Within 2 weeks of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ACTUAL)
June 1, 2018
Study Completion (ACTUAL)
June 1, 2018
Study Registration Dates
First Submitted
June 6, 2014
First Submitted That Met QC Criteria
June 9, 2014
First Posted (ESTIMATE)
June 11, 2014
Study Record Updates
Last Update Posted (ACTUAL)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00027784
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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