MRI in Staging Ovarian Cancer Using MRI Contrast Agent | NCT00463996

Studies
MRI in Staging Ovarian Cancer Using MRI Contrast Agent

NCT00463996

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Apr 20, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

Countries

Not provided

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

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Estimated

First Submitted Date

Apr 18, 2007

First Submission Date that Met QC Criteria

Apr 18, 2007

First Posted Date

Apr 20, 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

Apr 18, 2007

Last Update Posted Date

Apr 20, 2007Estimated

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

Can MRI be used to stage ovarian cancer?

Detailed Description

Staging of ovarian cancer can best be performed with CT or MRI compared to ultrasound. Studies have shown an increase in pos. predictive value by adding contrast i.v. to the MR-examination protocol. We compare staging of ovarian cancer by 1.MRI without contrast (standard method) to 2.MRI with contrast agent i.v. (new method)in the same patient. Golden standard are findings at operation.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspicion of ovarian cancer

Exclusion Criteria:

recurrence of disease
contraindication to MRI, contrast agent
inoperable patients for other reasons

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liselotte Ibsen, doc	Contact	+4589495201
Erik Lundorf, consultant	Contact	+4589495251		elu@sks.aaa.dk

Overall Officials

Name	Affiliation	Role
Liselotte Ibsen, doc	Aarhus University Hospital, BDA, Skejby	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided