Diagnosis of Bone Metastases in Breast Cancer: Bone Scint... | NCT01224873

Studies
Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET

NCT01224873

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Jan 11, 2011Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

Breast Cancer

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

Oct 2010

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

Oct 2010

Primary Completion Date

Oct 2012Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

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

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is superior to bone scintigraphy with technetium. On the other side, the investigators would like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.

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

110Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically proven c. mammae
clinically suspicion of bone metastases

Exclusion Criteria:

age under 18 years
diabetes mellitus
pregnancy
other known malignant disease

Accepts Healthy Volunteers

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

breast cancer patients who are treated at Rigshospitalet, DK

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christine Winkler, Dr.	Contact			christine.winkler@rh.regionh.dk

Overall Officials

Name	Affiliation	Role
Christine Winkler, Dr.	Dep. of Nuclear Medicine & PET, Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep. of Nuclear Medicine & PET, Rigshospitalet	Recruiting	Copenhagen		2100	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