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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


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To evaluate the accuracy of preoperative 18FDG PEM

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Maxine Jochelson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-189

NCT ID:

NCT01249157

Start Date:

November 2010

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • MRI
  • PEM
  • 10-189
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021