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

NCT ID: NCT01241721

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Breast Cancer; Breast Cancer Surgery

Keywords

Breast Diseases; Breast Neoplasms; Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Positron Emission Mammography (PEM)

Positron Emission Mammography (PEM)

Group Type: EXPERIMENTAL

Positron Emission Mammography (PEM)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. David Beatty, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center Cancer Institute

Locations

Swedish Cancer Institute

Seattle, Washington, United States

Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

CRC 09096

Identifier Type: -

Identifier Source: org_study_id