Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

NCT00981812 | Completed Results

• 1 other identifier: Cincinnati-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

PET; PEM; Positron Emission Mammography; Breast Biopsy

Outcome Measures

Primary Outcomes (1)

• Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.

  At time of biopsy

Study Arms (1)

PEM Breast Biopsy

EXPERIMENTAL

All patients underwent PEM biopsy.

Procedure: PEM Breast Biopsy

Interventions

PEM Breast Biopsy PROCEDURE

Breast biopsy using PEM guidance and Stereo Navigator software

Also known as: Naviscan PEM 2400 Pet Scanner, Stereo Navigator Accessory

PEM Breast Biopsy

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

UC Hospital, The Barrett Center

Cincinnnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mary Mahoney, MD
• Organization: University of Cincinnati Medical Center

mary.mahoney@uchealth.com

513-584-4396

Study Officials

• Mary C Mahoney, MD

  Univeristy of Cincinnati

  PRINCIPAL INVESTIGATOR

• Amy Argus, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Breast Imaging

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Locations

US (1)