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Sentinel Node With Ultrasound Contrast in Melanoma

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ultrasound contrast
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Malignant melanoma on a extremity, No spread of the cancer, Patients over 18 years old, Exclusion Criteria: Pregnancy, Lactating, Severe hart disease,

Sites / Locations

  • Copenhagen univercity hospital, Department of Radiology, section of ultrasound

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 29, 2006
Last Updated
June 17, 2008
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00370136
Brief Title
Sentinel Node With Ultrasound Contrast in Melanoma
Official Title
Sentinel Node Diagnostics With Ultrasound Contrast in Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2008 (undefined)
Study Completion Date
April 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

Brief Summary
The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be detected by lymph contrast ultrasound. In comparing the patients will also get lymph-scintigraphy and sentinel node detection wiht blue dye. The goal is to improve the method for detecting sentinel node(s) in melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ultrasound contrast

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Malignant melanoma on a extremity, No spread of the cancer, Patients over 18 years old, Exclusion Criteria: Pregnancy, Lactating, Severe hart disease,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Nielsen, MDSc
Organizational Affiliation
Department of Radiology, section ultrasound
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen univercity hospital, Department of Radiology, section of ultrasound
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Sentinel Node With Ultrasound Contrast in Melanoma

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