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COMPLETEDNANCT00981812

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 stu...

Lead sponsor: University of Cincinnati•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Cincinnati

See brief summary.

Age

25 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 4, 2016Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment20

Start dateSep 2009

Last updatedApr 4, 2016

Condition

Locations shown

UC Hospital, The Barrett Center

Cincinnnati, Ohio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2016Data synced to Clareo: June 27, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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