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

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.

Completed

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Acronym: MEL50

Important dates

Study start: 2008
First posted: Jun 3, 2009
Registry last updated: Oct 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed