Intraoperative Gamma Probe Localization of the Ureter

NCT00587548 | Terminated DMC

• 2 other identifiers: 79-06MCJ092006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to find a different way to identify the ureters during an abdominal operation. During some operations, the operating physician must identify where the ureters are to prevent injury to them. Typically, the surgeon calls the urologist to thread a small scope with a camera into the urethra (where the urine comes out) to place a wire into each of the two ureters to locate them. Instead of this procedure, we will inject a small amount of a radioactive chemical dye (TC99-DTPA)through a vein in your arm. The ureters can then be detected by a hand held probe called the 'gamma probe.' The TC99-DTPA dye passes through the body and is excreted through the urine. The goal of this study is that this probe will alert the physician when it placed directly over the ureters since the TC99-DTPA dye will highlight the ureters as the flow of urine goes through them.

Conditions

Abdominal Surgery

Keywords

locate the ureters during abdominal surgery

Outcome Measures

Primary Outcomes (1)

• If gamma probe localization of the ureters is possible, the need for ureteral stent placement could be obviated.

  Intraoperative procedure

Interventions

Localizing the ureters during surgery OTHER

One-time injection 4.5mCi of 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA) prior to the time of ureteral localization. The Neoprobe 2000 gamma probe will be utilized for ureter location.

Also known as: 4.5cmCi 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA), Neoprobe 2000 gamma probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agrees to informed consent.
• Patients undergoing elective, open, abdominal surgery
• years or older
• Normal renal function defined by a serum creatinine less than 1.5mg/dL

You may not qualify if:

• Pregnant or lactating females

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Study Officials

• Manpreet Grewal, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: January 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

US (1)