Breast Cancer
Conditions
Brief summary
The purpose of this study is to determine if PEM scan can improve axillary lymph node staging by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM stands for positron emission mammography, a relatively new and advanced application of positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose and treat disease.
Detailed description
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
Interventions
Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).
Exclusion criteria
* Children (\<18 years old) * Pregnant or Lactating women * Diabetic patients (Type I or II) * Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM * Patients who have NOT undergone a standard of care bilateral breast MRI at UC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer | PEM was performed prior to surgery and LN sampling immediately following surgery | Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as normal or abnormal. Lymph Node (LN) sampling and histopathology determined true positives and true negatives. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positron Emission Mammography Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm). | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No pathological lab value | 1 |
| Overall Study | Transferred to another hospital | 2 |
Baseline characteristics
| Characteristic | Positron Emission Mammography |
|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 36 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 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer
Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as normal or abnormal. Lymph Node (LN) sampling and histopathology determined true positives and true negatives.
Time frame: PEM was performed prior to surgery and LN sampling immediately following surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Positron Emission Mammography | Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer | Sensitivity | 83.3 percentage of subjects |
| Positron Emission Mammography | Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer | Specificity | 52.0 percentage of subjects |