Back to resultsUsing Diagnostic Tools to Stage Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients Diagnosed with Breast Cancer
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00367666
First Posted
August 22, 2006
Last Updated
March 2, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00367666
Brief Title
Using Diagnostic Tools to Stage Breast Cancer
Official Title
Evaluation of Multimodality Breast Imaging: Lesion Staging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2002 (Actual)
Primary Completion Date
March 12, 2024 (Anticipated)
Study Completion Date
March 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients Diagnosed with Breast Cancer
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abass Alavi, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Using Diagnostic Tools to Stage Breast Cancer
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