Clinical Application of Breast Blood-oxygen Functional Im... | NCT01678170

Studies
Clinical Application of Breast Blood-oxygen Functional Imaging Technology

NCT01678170

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Dec 22, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Breast Diseases

Interventions

Not provided

Countries

China

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

May 2012

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

Sep 2012

Primary Completion Date

Nov 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Aug 30, 2012

First Submission Date that Met QC Criteria

Aug 31, 2012

First Posted Date

Sep 3, 2012Estimated

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

Dec 21, 2015

Last Update Posted Date

Dec 22, 2015Estimated

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

This trial is going to evaluate the value of blood-oxygen functional imaging technology in the diagnosis of breast diseases.

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

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female older than 18 years breast lump received breast ultrasound and mammography

Exclusion Criteria:

After core-needle biopsy or resection After neoadjuvant chemotherapy, radiotherapy or endocrine therapy

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

Female with breast lump, received breast ultrasound and mammography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peifang Liu, M.D.	Contact	+86-22-23524536		cjr.liupeifang@vip.163.com

Overall Officials

Name	Affiliation	Role
Peifang Liu, M.D.	Department of Breast Imaging, Tianjin Medical University Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Breast Imaging, Tianjin Medical University Cancer Hospital	Recruiting	Tianjin	Tianjin Municipality	300060	China

Condition Browse Module

MeSH Terms

ID	Term
D001941	Breast Diseases
D004194	Disease

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided