Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma — Mel54  

Melanoma Clinical Trial

Official title: Evaluation Of Mobile Gamma Camera Imaging For Sentinel Node Biopsy In Melanoma Independent Of Fixed Gamma Camera Imaging

Status Completed

Clinical Trial Summary

This is a single-institution study seeking to evaluate if mobile gamma camera imaging can be used independent of standard fixed gamma camera imaging in patients undergoing sentinel node biopsy for melanoma.

Clinical Trial Description

Patients who are scheduled to undergo sentinel node biopsy as part of recommended clinical care will be offered participation in this study.

Patients enrolled in this study will receive standard lymphoscintigraphy in nuclear medicine; however, these images will not be reviewed by the investigator until the preoperative mobile gamma camera(MGC)images have been obtained. Upon completion of the preoperative MGC imaging, the investigator will define the location of SLNs and the plan for the surgical approach. The investigator will then review the FGC images and assess the agreement of these two imaging methodologies. The hand-held gamma probe will be used to further evaluate the patient at this time and a final determination of true hot spots will be made based on the information and the clinical judgment of the operating surgeon. The final surgical plan will be decided. The primary data to be obtained from this cohort will be confirmation of the use of MGC imaging as a screening device to identify all nodal basins containing SLNs.

An additional goal of this study will be to identify techniques that may improve the use of the MGC and opportunities for optimizing the MGC device and imaging system. To the extent possible, improvements to the system will be made incrementally. A goal is to have a more optimized system before the next trial.

In addition to the preoperative imaging data discussed above, the participants will be reevaluated intraoperatively with a MGC and the hand-held probe at the following time points:

1. after removal of each sentinel node

2. after completion of the sentinel node biopsy procedure In each of these assessments, the following will be recorded: the number and location of sentinel nodes, the correspondence with preoperative hot spots determined by the clinical gamma detection devices (fixed camera, MGC and hand-held probe), the time required for imaging, and technical features of use, advantages, and limitations of the MGC imaging system. The individual sentinel nodes will be imaged ex vivo and counted with the hand-held probe. ;

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT01531608
• Study type: Observational
• Source: University of Virginia
• Status: Completed
• Start date: March 2011
• Completion date: February 2012