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


Phase 4
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To measure response to neoadjuvant chemotherapy in patients with breast cancer.

Outcome Description:

analysis of three patients pilot data in progress

Outcome Time Frame:

one and a half years

Safety Issue:

No

Principal Investigator

Kirti Kulkarni, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Chicago Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

16895A

NCT ID:

NCT01012440

Start Date:

November 2009

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

The University of Chicago Medical CenterChicago, Illinois  60637-1470