Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Device: PEM Flex Solo II PET Scanner; Device: MRI scan

• Registration Number: NCT01012440
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this study is:

1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?

2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Detailed Description

Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Study Timeline

• Study First Submitted: 2009-06-25
• Study Start: 2009-11
• Study First Submitted QC: 2009-11-11
• Study First Posted: 2009-11-13
• Primary Completion: 2011-05
• Study Completion: 2012-05
• Results First Submitted: 2015-05-27
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-29
• Last Update Submitted: 2015-06-29
• Results First Posted: 2015-07-27
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)

Exclusion Criteria

• Children (< 18 years old)
• Pregnant or Lactating women
• Diabetic patients (Type I or II)
• Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
• Patients who have NOT undergone a standard of care bilateral breast MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Beast cancer subjects	PEM Flex Solo II PET Scanner	Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
Beast cancer subjects	MRI scan	Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods

Primary Outcome Measures

Name	Time	Method
Reduction in Tumor Size	1-2 weeks post treatment onset	Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.

Trial Locations

Locations (1)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States