Trial record 7 of 74 for:    Open Studies | mammography

Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Swedish Medical Center
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01241721
First received: October 6, 2010
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

The purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.


Condition Intervention
Breast Cancer
Breast Cancer Surgery
Device: Positron Emission Mammography (PEM)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Value of Pre-Surgery Positron Emission Mammography (PEM) in Patients With Newly Diagnosed Breast Cancer

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • PEM identification of primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers. [ Time Frame: After the first 30 subjects (~one year) ] [ Designated as safety issue: No ]
  • Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]
  • Comparison of PEM and MRI for identification of index primary breast cancer and unsuspected primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]
  • Comparison of PEM and MRI for identification of breast lesions that require biopsy but are not an unsuspected 2nd primary breast cancer in patients with known index primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positron Emission Mammography (PEM)
Positron Emission Mammography (PEM)
Device: Positron Emission Mammography (PEM)
Phase 1 of the study will involve imaging the breast with cancer up to 3 times over 2 hours using one half (1/2) of the standard dose of the radioactive tracer, F18FDG, for PEM imaging. If this reduced dose is equivalent to the standard dose then one quarter (1/4) dose will be tested to find the lowest effective radiation dose of tracer to see breast cancer. Phase 2 of the study will involve imaging of both breasts several times over a shorter duration using the lowest effective dose of tracer identified in the first part of the study. This will allow us to examine the reliability of PEM to identify a second unsuspected abnormality in either breast. Patients will be offered biopsy by ultrasound, MRI or PEM as clinically appropriate of lesions suspected of being cancer prior to final surgical planning.

Detailed Description:

The purpose of this research in Phase 1 is to determine the lowest dose of radionuclide 18F-FDG that can be used in the Diagnostic use of Positron Emission Mammography for the diagnosis of multifocal breast cancer in patients wishing to have Breast Conservation Surgery for newly diagnosed breast cancer. Low dose injections (radioactive counts) of 18F-FDG will be compared to the equivalent radioactive counts for the standard higher dose 10 millicuries used in standard PEM studies in current clinical practice. Images will be post processed by computer aided software and will be placed in two categories: Low dose group, and higher dose group. Images will be randomly blinded to readers to assess the ability to see positive lesions that warrant further biopsy or to include in current surgical planning prior to breast conservation surgery or mastectomy. Images will be assessed for ability to see the PEM positive lesions on the lower dose images and this will be compared to the ability to see the PEM positive lesions on the standard higher dose images. Each of three breast cancer categories will be assessed Infiltrating Ductal Carcinoma, Lobular infiltrating Carcinoma, and Ductal Carcinoma Insitu. Phase 1 will have 30 patients.

The purpose of the research in Phase 2 is to use the lowest dose identified in Phase 1 for imaging primary breast cancer patients who have been identified by breast MRI to have an unsuspected second lesion of the breast not expected from Mammography or Ultrasound that requires biopsy for diagnosis prior to the biopsy to compare the reliability of PEM and MRI for identifying breast cancer at the 2nd site. Parameters assessed will include standard statistical analysis for sensitivity, specificity, positive predictive value and negative predictive value for MRI and PEM imaging with the new lower radionuclide dose selected by Phase 1. Phase 2 will have 100 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be 18 years of age or older
  • Newly diagnosed primary breast cancer
  • Must have a breast or breast/chest MRI ordered as part of standard of care
  • Must meet one or more of the following in Part 1:

    • T1 carcinoma of the breast appropriate for breast conserving surgery diagnosis established by core biopsy
    • Tis (ductal carcinoma in situ) carcinoma > 2 cm diameter
    • Invasive lobular carcinoma of the breast
  • Must meet the following in Part 2:

    • Known invasive or in situ primary breast cancer identified on pre-surgical breast MRI to have an unsuspected 2nd lesion recommended for biopsy and biopsy has not yet been performed

Exclusion Criteria:

  • Known diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241721

Contacts
Contact: Sarah Fanizzi (206) 215-3086 CancerResearch@Swedish.org

Locations
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Sarah Fanizzi    206-215-3086    CancerResearch@Swedish.org   
Principal Investigator: J. David Beatty, M.D.         
Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center Recruiting
Seattle, Washington, United States, 98122
Contact: Sarah Fanizzi    206-215-3086    CancerResearch@Swedish.org   
Principal Investigator: J. David Beatty, M.D.         
Sponsors and Collaborators
Swedish Medical Center
Investigators
Principal Investigator: J. David Beatty, MD Swedish Medical Center Cancer Institute
  More Information

No publications provided

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01241721     History of Changes
Other Study ID Numbers: CRC 09096
Study First Received: October 6, 2010
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
Breast Diseases
Breast Neoplasms
Neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014