Using Diagnostic Tools to Stage Breast Cancer | NCT00367666

Studies
Using Diagnostic Tools to Stage Breast Cancer

NCT00367666

Sponsor

University of Pennsylvania

Status

Active, not recruiting

Last Update Posted

Mar 10, 2026Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)

Countries

United States

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

ID	Type	Description	Link
NIH funded

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2002Actual

Primary Completion Date

Mar 12, 2027Estimated

Completion Date

Mar 12, 2027Estimated

First Submitted Date

Aug 22, 2006

First Submission Date that Met QC Criteria

Aug 22, 2006

First Posted Date

Aug 23, 2006Estimated

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

Mar 9, 2026

Last Update Posted Date

Mar 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 project is aimed at investigating the relative diagnostic and synergy of four state of the art breast imaging techniques (magnetic resonance imaging (MRI), full-field digital mammography (DMAM), ultrasound, and positron emission tomography (PET)) with respect to determining the extent of breast cancer.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients Diagnosed with Breast Cancer	Experimental		Device: MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)	Device		Patients Diagnosed with Breast Cancer

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women recently diagnosed with Breast Cancer
Will be undergoing surgery (after study) at the Hospital of the University of Pennsylvania

Exclusion Criteria:

Contraindications to MRI
previously diagnosed with breast cancer (in the smae breast) within the past 5 years
Patients with known locally advanced cancer (prior to study entry) being treated with preoperative adjuvant therapy.
Pregnant women

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abass Alavi, MD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

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

Intervention Browse Module

MeSH Terms

ID	Term
D008327	Mammography
D014463	Ultrasonography
D049268	Positron-Emission Tomography

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided