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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014