Use of Bone Scintigraphy, CT and MRI in Breast Cancer | NCT00682253

Studies
Use of Bone Scintigraphy, CT and MRI in Breast Cancer

NCT00682253

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Sep 10, 2009Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Breast Neoplasms

Interventions

Not provided

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

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

May 21, 2008

First Posted Date

May 22, 2008Estimated

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

Sep 8, 2009

Last Update Posted Date

Sep 10, 2009Estimated

Description Module

Brief Summary

A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled the combination of functional and anatomical imaging. Its use in cancer patients has not yet been evaluated or validated against a relative gold stand or clinical follow up. The purposes of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in breast cancer patients

Detailed Description

Not provided

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

180Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological verified breast cancer
Age 18-80 years
Investigation for metastases using imaging modality/modalities planned
Written consent to participate in trial

Exclusion Criteria:

Overweight limiting the use of MRI
Metal parts in body
Claustrophobia
Allergy to contrast agents used in trial
Pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

women aged 18-80 years with suspicision of disseminated breast cancer seen at Dept. of Oncology, Aarhus University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anni Eskild-Jensen, MD, PhD, DMSci	Contact	+45 8949 2251		aej@ki.au.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital	Recruiting	Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided