Sentinel Node With Ultrasound Contrast in Melanoma

Malignant Melanoma Clinical Trial

Official title:

Sentinel Node Diagnostics With Ultrasound Contrast in Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370136
• Other study ID #: (KF)01288200
• Status: Completed
• Phase: N/A
• First received: August 29, 2006
• Last updated: June 17, 2008
• Start date: August 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Malignant melanoma on a extremity,

• No spread of the cancer,

• Patients over 18 years old,

Exclusion Criteria:

• Pregnancy,

• Lactating,

• Severe hart disease,

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• ultrasound contrast

Locations

Country	Name	City	State
Denmark	Copenhagen univercity hospital, Department of Radiology, section of ultrasound	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark,