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

NCT01012440 | Terminated Results DMC

• 1 other identifier: 16895A
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 1.To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
2. 2.To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Beast cancer subjects

EXPERIMENTAL

Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods

Device: PEM Flex Solo II PET Scanner; Device: MRI scan

Interventions

PEM Flex Solo II PET Scanner DEVICE

Subjects will receive bilateral (both sides) breast and axillary PEM scans.

Beast cancer subjects

MRI scan DEVICE

Subjects will receive bilateral (both sides) breast and axillary MRI scans.

Beast cancer subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Kirti Kulkarni
• Organization: University of Chicago

kkulkarni@radiology.bsd.uchicago.edu

(773) 702-2781

Study Officials

• Kirti Kulkarni, M.D.

  The University of Chicago Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-06

Locations

US (1)