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
About this trial
This is an interventional diagnostic trial for Malignant Melanoma
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,
Sites / Locations
- Copenhagen univercity hospital, Department of Radiology, section of ultrasound
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
Learn more about this trial
Sentinel Node With Ultrasound Contrast in Melanoma
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