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

This study has been terminated.
(Lack of accrual)
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01249157
First received: November 24, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Device: Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To evaluate the accuracy of preoperative 18FDG PEM [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To explore whether the results biomarkers are associated with the accuracy of 18FDG PEM and MRI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To explore whether the results of histology are associated with the accuracy of 18FDG PEM and MRI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI and PEM scans
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.
Device: Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI)
An additional 5 women will be enrolled at the beginning of the study for training purposes only and will not be included in the assessment of this study. Once the patient has had both breast MRI and PEM, the location of each site of potential breast cancer will be listed for each modality. The location of each abnormality on each imaging examination will be documented. Once the histopathologic evaluation has been performed, the pathology results will be compared to the imaging results for each modality. Furthermore, comparison of the performance of MRI and PEM will then be made with the pathological results as the truth. Comparison of the histology and biomarkers in each lesion detected by each modality will be done in order to determine if these factors affect detection by each modality.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249157

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Maxine Jochelson, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01249157     History of Changes
Other Study ID Numbers: 10-189
Study First Received: November 24, 2010
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
MRI
PEM
10-189

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014