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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00370136
Other study ID # (KF)01288200
Secondary ID
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


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, 

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