NCT00370136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 18, 2008

Status Verified

June 1, 2008

Enrollment Period

1.6 years

First QC Date

August 29, 2006

Last Update Submit

June 17, 2008

Conditions

Malignant Melanoma

Interventions

ultrasound contrastDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant melanoma on a extremity,
  • No spread of the cancer,
  • Patients over 18 years old,

You may not qualify if:

  • Pregnancy,
  • Lactating,
  • Severe hart disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen univercity hospital, Department of Radiology, section of ultrasound

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael B Nielsen, MDSc

    Department of Radiology, section ultrasound

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2006

First Posted

August 30, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

June 18, 2008

Record last verified: 2008-06

Locations

DK(1)