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Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers.
Participants: Adult patients with operable breast cancer that are being treated at UNC with neoadjuvant chemotherapy followed by potentially curative surgical resection.
Procedures (methods): Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment will undergo additional pre-treatment and post-treatment PET/MR. The response to treatment will be assessed at post-treatment by evaluating change in tumor size from MRI, change in response to dynamic contrast enhanced (DCE) MRI, and 18F-fluorodeoxyglucose (18F-FDG) avidity from PET. Patients will then undergo surgery. Their pathology will be reviewed for treatment effect as assessed by residual cancer burden (RCB) score. Patients will be followed and assessed for recurrence.
Investigators propose that the changes indicated by PET/MR imaging from pre-treatment to post-treatment time points will accurately predict the patient's response to neoadjuvant chemotherapy, providing useful prognostic and surgical-planning information. The study will enroll patients with operable breast cancer being treated with neoadjuvant chemotherapy followed by potentially curative surgical resection. The standard of care for these patients would not normally include PET imaging but may include MR imaging. Patients in the study will receive combined PET/MR imaging prior to treatment and following treatment. Then, patients will receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease. The pathology report will be reviewed for therapy treatment effect as assessed by Residual Cancer Burden (RCB) score. Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment. The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for RCB score. Patients will be followed with the intent of further correlating image measures with clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/MR | Experimental | Each patient will undergo two combined PET/MR scans. The pre-treatment and post-treatment combined PET/MR scans are for research purposes and not part of the patient's standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MR | Diagnostic Test | Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PET Activity Estimates From Pre-treatment to Post-treatment | Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score. | Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy | Quantitative image measures from PET and MR will be compiled and an optimal linear regression will be derived between the image metrics and the outcome measure from pathology, the RCB score. Prediction performance of the regression relation will be assessed using a leave-one-out cross-validation approach. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Lalush, PhD | UNC Biomedical Engineering | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC- Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Cancer Patients | Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Cancer Patients | Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in PET Activity Estimates From Pre-treatment to Post-treatment | Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score. | Single subject did not complete the second scan, so outcome measure could not be assessed. | Posted | Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery. |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Cancer Patients | Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Lalush | North Carolina State University | 919-513-7671 | dslalush@ncsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2017 | Feb 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pre-surgery PET-MR scan tumor size | Mean | Standard Deviation | millimeters |
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| Secondary | Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy | Quantitative image measures from PET and MR will be compiled and an optimal linear regression will be derived between the image metrics and the outcome measure from pathology, the RCB score. Prediction performance of the regression relation will be assessed using a leave-one-out cross-validation approach. | Single subject did not complete the second scan, so outcome measure could not be assessed. | Posted | Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery. |
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| D017437 |
| Skin and Connective Tissue Diseases |