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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01668 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 7587 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| P50CA138293 | U.S. NIH Grant/Contract | View source | |
| RG1712020 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to end of funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES:
I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy.
II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue.
OUTLINE:
Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (FDG PET and DCE-MRI) | Experimental | Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | Undergo FDG PET |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Favorable Pathologic Response at Surgery | The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:
| At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response | Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Baseline to up to 12 weeks (mid-therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Specht | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37946201 | Derived | Kazerouni AS, Peterson LM, Jenkins I, Novakova-Jiresova A, Linden HM, Gralow JR, Hockenbery DM, Mankoff DA, Porter PL, Partridge SC, Specht JM. Multimodal prediction of neoadjuvant treatment outcome by serial FDG PET and MRI in women with locally advanced breast cancer. Breast Cancer Res. 2023 Nov 9;25(1):138. doi: 10.1186/s13058-023-01722-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (FDG PET and DCE-MRI) | Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| positron emission tomography | Device | Undergo FDG PET |
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| dynamic contrast-enhanced magnetic resonance imaging | Device | Undergo DCE-MRI |
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| laboratory biomarker analysis | Other | Correlative studies |
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| Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response | Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Baseline to up to 12 weeks (mid-therapy) |
| Time From Surgery to Breast Cancer Recurrence | Mean (range) | The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status. |
| Time of Surgery to Overall Survival | Mean (range) | Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive. |
| Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response | Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Baseline to up to 12 weeks (mid-therapy) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (FDG PET and DCE-MRI) | Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Clinical stage | Count of Participants | Participants |
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| 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 | Number of Participants With Favorable Pathologic Response at Surgery | The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:
| Posted | Count of Participants | Participants | At time of surgery |
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| Secondary | Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response | Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Three participants had to be excluded from this analysis:
| Posted | Median | Full Range | percent change | Baseline to up to 12 weeks (mid-therapy) |
| |||||||||||||||||||||||||||
| Secondary | Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response | Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | Three participants had to be excluded from this analysis:
| Posted | Median | Full Range | percent change | Baseline to up to 12 weeks (mid-therapy) |
| |||||||||||||||||||||||||||
| Secondary | Time From Surgery to Breast Cancer Recurrence | Mean (range) | At the time of final analysis, 7 of the 35 patients (20%) had recurrence. | Posted | Mean | Full Range | years- recurrence free | The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status. |
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| Secondary | Time of Surgery to Overall Survival | Mean (range) | At the time of final analysis, 4 of the 35 patients (11%) had died. | Posted | Mean | Full Range | years- overall survival | Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive. |
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| Secondary | Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response | Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response. | One participant had to be excluded from this analysis: [1] pathologic response could not be evaluated due to a metastatic disease progression prior to surgery. | Posted | Median | Full Range | percent change | Baseline to up to 12 weeks (mid-therapy) |
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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 | Diagnostic (FDG PET and DCE-MRI) | Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery). fludeoxyglucose F 18: Undergo FDG PET positron emission tomography: Undergo FDG PET dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI laboratory biomarker analysis: Correlative studies | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Specht, MD | University of Washington | 206-288-6889 | jspecht@uw.edu |
| ID | Term |
|---|---|
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D000098543 | Dynamic Contrast Enhanced Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D008279 | Magnetic Resonance Imaging |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| IIIB |
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| IIIC |
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