New Indications for Ultrasound in the Staging of Cervical... | NCT00451945

Studies
New Indications for Ultrasound in the Staging of Cervical Cancer

NCT00451945

Sponsor

Rigshospitalet, Denmark

Status

Withdrawn

Last Update Posted

Jun 18, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Cervical Cancer

Interventions

biopsy
3d-ultrasound and fusion of UL and PET/CT

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Mar 2008

First Submitted Date

Mar 23, 2007

First Submission Date that Met QC Criteria

Mar 23, 2007

First Posted Date

Mar 26, 2007Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer.

3-D-ultrasound of the tumour to estimate its volume and local spread
Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.

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

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cervical cancer,
PET/CT pos. lymph nodes,
Patients over 18 years old

Exclusion Criteria:

Pregnancy,
Lactating,
Diabetic

Accepts Healthy Volunteers

Not provided

Sex

Female

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 of 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
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy
D014463	Ultrasonography
D000072078	Positron Emission Tomography Computed Tomography

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
biopsy	Procedure
3d-ultrasound and fusion of UL and PET/CT	Device