An interventional study of Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI) in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Terminated at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic
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.
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
To Evaluate the Accuracy of Preoperative 18FDG PEM
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.
Time frame: 2 years
| Milestone | Preoperative 18FDG PEM and MRI |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preoperative 18FDG PEM and MRI | — | 0/1 (0%) | 0/1 (0%) |
The first 5 patients who consent to the study will be intended for training purposes only.
| Age, Categorical(Participants) | Preoperative 18FDG PEM and MRI |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Preoperative 18FDG PEM and MRI |
|---|---|
| Female | 1 |
| Male | 0 |
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center