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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01249157

10-189

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

MRI and PEM scans

Experimental group

Description:

All consenting patients who are to have staging breast MRI, will be offered 18FDG PEM (Positron Emission Mammography) within 30 days. If the patient had a previous breast MRI that was done within 30 days at an outside institution, this MRI can be used if a radiologist determines that it is an adequate study. The surgery date will not be affected by the additional PEM evaluation. All imaging will be done and reviewed by MSKCC breast imagers. MRI and PEM findings suggestive of malignancy will be prospectively recorded in both the ipsilateral and contralateral breast.

Treatment:

Device: Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI)