Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00981812
• Other study ID #: Cincinnati-01
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2009
• Last updated: March 2, 2012
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2012
• Source: University of Cincinnati
• Contact: Monene M Kamm, AS
• Phone: 513-584-2916
• Email: kammmm[@]ucmail.uc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.

Description:

See brief summary.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• PEM Breast Biopsy
Breast biopsy using PEM guidance and Stereo Navigator software

Locations

Country	Name	City	State
United States	UC Hospital, The Barrett Center	Cincinnnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence that breast biopsy can be performed using PEM and Stereo Navigator software		At time of biopsy	No
Secondary	Evidence that breast biopsy can be performed in less clinical visits than if biopsy is performed using MRI, mammogram, and/or ultrasound		At time of final pathology diagnosis	No