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Using Diagnostic Tools to Stage Breast Cancer

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00367666
Collaborator
(none)
400
Enrollment
1
Location
1
Arm
252.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI, Digital Mammography, Ultrasound and Positron Emission Tomography (PET)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Multimodality Breast Imaging: Lesion Staging
Actual Study Start Date :
Mar 1, 2002
Anticipated Primary Completion Date :
Mar 12, 2023
Anticipated Study Completion Date :
Mar 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients Diagnosed with Breast Cancer

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Abass Alavi, MD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT00367666
    Other Study ID Numbers:
    • Protocol 414500
    • NIH funded
    • NCT00194337
    First Posted:
    Aug 23, 2006
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Mar 2, 2022