Sentinel Node With Ultrasound Contrast in Melanoma | NCT00370136

Studies
Sentinel Node With Ultrasound Contrast in Melanoma

NCT00370136

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Jun 18, 2008Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Malignant Melanoma

Interventions

ultrasound contrast

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Mar 2008

Completion Date

Apr 2008

First Submitted Date

Aug 29, 2006

First Submission Date that Met QC Criteria

Aug 29, 2006

First Posted Date

Aug 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2008

Last Update Posted Date

Jun 18, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
ultrasound contrast	Drug

Eligibility Module

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,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael B Nielsen, MDSc	Department of Radiology, section ultrasound	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen univercity hospital, Department of Radiology, section of ultrasound		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided