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

NCT01241721 | Completed

• 1 other identifier: CRC 09096
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Breast Cancer Surgery

Keywords

Breast Diseases; Breast Neoplasms; Neoplasms

Outcome Measures

Primary Outcomes (1)

• PEM identification of primary breast cancer.

  Upon study completion (~3 years)

Secondary Outcomes (4)

• Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers.

  After the first 30 subjects (~one year)

• Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer.

  Upon study completion (~3 years)

• Comparison of PEM and MRI for identification of index primary breast cancer and unsuspected primary breast cancer.

  Upon study completion (~3 years)

• 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)

Study Arms (1)

Positron Emission Mammography (PEM)

EXPERIMENTAL

Positron Emission Mammography (PEM)

Device: Positron Emission Mammography (PEM)

Interventions

Positron Emission Mammography (PEM) 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.

Positron Emission Mammography (PEM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known diabetes mellitus

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (2)

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• J. David Beatty, MD

  Swedish Medical Center Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: November 16, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

US (2)