Breast Cancer
Conditions
Keywords
MRI, PEM, 10-189
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.
Interventions
DEVICEPositron 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Accuracy of Preoperative 18FDG PEM | 2 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preoperative 18FDG PEM and MRI Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Preoperative 18FDG PEM and MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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
Population: No data displayed because Outcome Measure has zero total participants analyzed.