Know Cancer

or
forgot password

Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer


N/A
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer


See brief summary.


Inclusion Criteria:



- female

- subject is 25-100 years of age

- subjects has at least one breast imaging finding on mammography and/or ultrasound
which is assessed as highly suggestive of malignancy and recommended to biopsy

- subject is able to provide informed consent

Exclusion Criteria:

- subject is pregnant

- subject is actively lactating or discontinued breastfeeding less than 2 months ago

- subject has breast implants

- subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24
hours of the PEM study

- subject has contraindications for core biopsy and other invasive procedures

- subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus

- subject has had surgery or radiation therapy on the study breast or has had
chemotherapy within the past 12 months

- subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting
blood glucose level greater than 140 mg/dl on day of PEM imaging

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evidence that breast biopsy can be performed using PEM and Stereo Navigator software

Outcome Time Frame:

At time of biopsy

Safety Issue:

No

Principal Investigator

Mary C Mahoney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univeristy of Cincinnati

Authority:

United States: Institutional Review Board

Study ID:

Cincinnati-01

NCT ID:

NCT00981812

Start Date:

September 2009

Completion Date:

April 2012

Related Keywords:

  • Breast Cancer
  • PET
  • PEM
  • Positron Emission Mammography
  • Breast Biopsy
  • Breast Neoplasms

Name

Location

UC Hospital, The Barrett CenterCincinnnati, Ohio  45219