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

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ClinicalTrials.gov Identifier: NCT00912730
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : October 21, 2009
Sponsor:
Information provided by:
University of Virginia

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.

Condition or disease
Melanoma

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma
Study Start Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma
U.S. FDA Resources




Primary Outcome Measures :
  1. Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary)

Secondary Outcome Measures :
  1. sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009

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