Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer
Primary Purpose
Breast Cancer, Breast Cancer Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positron Emission Mammography (PEM)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Diseases, Breast Neoplasms, Neoplasms
Eligibility 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
Sites / Locations
- Swedish Cancer Institute
- Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Positron Emission Mammography (PEM)
Arm Description
Positron Emission Mammography (PEM)
Outcomes
Primary Outcome Measures
PEM identification of primary breast cancer.
Secondary Outcome Measures
Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers.
Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer.
Comparison of PEM and MRI for identification of index primary breast cancer and unsuspected primary breast cancer.
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.
Full Information
NCT ID
NCT01241721
First Posted
October 6, 2010
Last Updated
November 16, 2016
Sponsor
Swedish Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01241721
Brief Title
Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer
Official Title
Clinical Value of Pre-Surgery Positron Emission Mammography (PEM) in Patients With Newly Diagnosed Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Surgery
Keywords
Breast Diseases, Breast Neoplasms, Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positron Emission Mammography (PEM)
Arm Type
Experimental
Arm Description
Positron Emission Mammography (PEM)
Intervention Type
Device
Intervention Name(s)
Positron Emission Mammography (PEM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PEM identification of primary breast cancer.
Time Frame
Upon study completion (~3 years)
Secondary Outcome Measure Information:
Title
Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers.
Time Frame
After the first 30 subjects (~one year)
Title
Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer.
Time Frame
Upon study completion (~3 years)
Title
Comparison of PEM and MRI for identification of index primary breast cancer and unsuspected primary breast cancer.
Time Frame
Upon study completion (~3 years)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. David Beatty, MD
Organizational Affiliation
Swedish Medical Center Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer
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