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

Breast Cancer Clinical Trial

Official title:

Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01012440
• Other study ID #: 16895A
• Status: Terminated
• Phase: N/A
• First received: June 25, 2009
• Last updated: June 29, 2015
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• PEM Flex Solo II PET Scanner
Subjects will receive bilateral (both sides) breast and axillary PEM scans.
• MRI scan
Subjects will receive bilateral (both sides) breast and axillary MRI scans.

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Tumor Size	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.	1-2 weeks post treatment onset	No