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Completed

NCT Number: NCT00981812

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

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.

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Key information

Conditions

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

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC Hospital, The Barrett Center

Cincinnnati, Ohio, 45219, United States

About this study

See brief summary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEM Breast Biopsy

Procedure

Breast biopsy using PEM guidance and Stereo Navigator software

Other names: Naviscan PEM 2400 Pet Scanner, Stereo Navigator Accessory

Primary outcomes

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

    Time frame: At time of biopsy

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 22, 2009
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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