Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoper... | NCT02160925

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

NCT02160925

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jul 30, 2019Actual

Enrollment

125Actual

Phase

Not Applicable

Conditions

Clinical T1 Renal Mass

Interventions

Preoperative 99mTc-Sestamibi SPECT/CT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Jun 6, 2014

First Submission Date that Met QC Criteria

Jun 9, 2014

First Posted Date

Jun 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2019

Last Update Posted Date

Jul 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preoperative 99mTc-Sestamibi SPECT/CT	Experimental		Other: Preoperative 99mTc-Sestamibi SPECT/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative 99mTc-Sestamibi SPECT/CT	Other		Preoperative 99mTc-Sestamibi SPECT/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection.		Within 2 weeks of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamad Allaf, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States