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

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The University of Chicago

Status

Terminated

Conditions

Breast Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01012440
16895A

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Beast cancer subjects
Experimental group
Description:
Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
Treatment:
Device: PEM Flex Solo II PET Scanner
Device: MRI scan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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