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

Breast Cancer Clinical Trial

Official title:

Clinical Value of Pre-Surgery Positron Emission Mammography (PEM) in Patients With Newly Diagnosed Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241721
• Other study ID #: CRC 09096
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: November 16, 2016
• Start date: September 2010
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Surgery
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Swedish Cancer Institute	Seattle	Washington
United States	Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PEM identification of primary breast cancer.		Upon study completion (~3 years)	No
Secondary	Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers.		After the first 30 subjects (~one year)	No
Secondary	Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer.		Upon study completion (~3 years)	No
Secondary	Comparison of PEM and MRI for identification of index primary breast cancer and unsuspected primary breast cancer.		Upon study completion (~3 years)	No
Secondary	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.		Upon study completion (~3 years)	No