A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma (MEL50)

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00912730
First received: June 1, 2009
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

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.


Condition
Melanoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary) [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with melanoma scheduled to undergo sentinel node biopsy as part of recommended clinical care, age 18 years or older.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912730

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Craig L Slingluff, MD University of Virginia
  More Information

No publications provided

Responsible Party: Craig L Slingluff, MD, University of Virginia - Human Immune Therapy Center
ClinicalTrials.gov Identifier: NCT00912730     History of Changes
Other Study ID Numbers: 13565
Study First Received: June 1, 2009
Last Updated: October 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
melanoma
imaging
sentinel node
biopsy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 22, 2014