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Clinical Trials/NCT00912730
NCT00912730CompletedNot Applicable

A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma

University of Virginia1 site in 1 country20 target enrollmentStarted: August 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary)

Study Overview

Brief Summary

This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years of age or older, AND
  • plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid.

Exclusion Criteria

  • under 18 years of age,
  • unable to give informed consent, OR
  • not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid.

Outcomes

Primary Outcomes

Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary)

Secondary Outcomes

  • sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary)

Investigators

Sponsor Class
Other

Study Sites (1)

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