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Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast

Not Applicable
Terminated
Conditions
Breast Cancer
Registration Number
NCT01249157
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary

Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast that uses a radioactive glucose based tracer, which is a form of sugar attached to a low radiation agent, to detect cancer cells. The radioactive glucose based tracer is called fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA approved. This type of imaging may be able to see the breast cancer before it could be seen with mammograms and may be as good as or better than breast MRI.

The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM) with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with breast cancer. This study will also perform special pathology test to compare the FDG PEM and contrast enhanced breast MRI images with the results from the standard of care breast surgery. This may teach us more about the biology of each breast tumor.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
6
Inclusion Criteria
  • Female patients with recently diagnosed invasive or in situ breast cancer by core needle biopsy or FNA (confirmed at MSKCC) prior to enrollment.
  • Patients planning treatment with mastectomy at MSKCC.
  • Patients 21 years old or older.
  • Patients who had or are having a breast MRI within 30 days or less of PEM.
  • Patients who had or are having a digital mammogram.
Exclusion Criteria
  • Patients who are pregnant or breast feeding.
  • Patients with prior radiation therapy or endocrine therapy.
  • Patients who had a prior lumpectomy.
  • Patients who are diabetic.
  • Patients with moderate to end stage kidney disease.
  • Patients who have a contraindication to MRI (i.e. pacemaker, metallic implants, etc).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
To Evaluate the Accuracy of Preoperative 18FDG PEM2 years

using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States

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