NCT00912730

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
Last Updated

October 21, 2009

Status Verified

October 1, 2009

First QC Date

June 1, 2009

Last Update Submit

October 20, 2009

Conditions

Melanoma

Keywords

melanomaimagingsentinel nodebiopsy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Craig L Slingluff, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

August 1, 2008

Last Updated

October 21, 2009

Record last verified: 2009-10

Locations

US(1)