Sentinel Node With Ultrasound Contrast in Melanoma

This study has been completed.

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00370136

Purpose

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.

Condition	Intervention
Malignant Melanoma	Drug: ultrasound contrast

MedlinePlus related topics: Melanoma Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Sentinel Node Diagnostics With Ultrasound Contrast in Melanoma

Further study details as provided by Rigshospitalet, Denmark:

Estimated Enrollment:	20
Study Start Date:	August 2006
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370136

Locations

Denmark
Copenhagen univercity hospital, Department of Radiology, section of ultrasound
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Michael B Nielsen, MDSc

Department of Radiology, section ultrasound

More Information

Study ID Numbers:	(KF)01288200
Study First Received:	August 29, 2006
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00370136
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 15, 2009