| Primary | %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response | The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies | Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) | Posted | | Mean | Standard Deviation | percentage change of SUVmax | | Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL): H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC >= 0.75 AUC = ROC(%ΔSUVmax| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100 | Delong method | | 0.046 | The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one-sided p value DeLong ER, DeLong DM, Clarke-Pearson DL, Biometrics (1988) | AUC | 0.68 | Standard Error of the Mean | 0.10 | 1-Sided | 95 | | .83 | | | |
|
| Secondary | Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET) | For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 . Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells. | 1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data | Posted | | Mean | Standard Deviation | Standard Uptake Values (SUVmax) | | Baseline (FLT-1) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |
| Secondary | Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC) | For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells. | 43 patients who had suitable post-NAC tissue samples for correlation between surgical specimens and FLT3 SUVs | Posted | | Mean | Standard Deviation | Standard Uptake Values (SUVmax) | | Post-NAC (FLT3) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |
| Secondary | SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein. Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III | @ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III | Posted | | Mean | Standard Deviation | Standard Uptake Values (SUVmax) | | Baseline (FLT-1) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |
| Secondary | SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein. Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III | after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III | Posted | | Mean | Standard Deviation | Standard Uptake Values (SUVmax) | | early treatment (FLT2) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |
| Secondary | SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III | The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein. | After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III | Posted | | Mean | Standard Deviation | Standard Uptake Values (SUVmax) | | post-NAC (FLT-3) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |
| Secondary | Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor | To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome. Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section | 43 patients who had both FLT1 and FLT3 scans | Posted | | Mean | Standard Deviation | percentage change in SUVmax | | Baseline (FLT-1) and post-NAC (FLT-3) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. CT: Undergo 18F-FLT PET/CT 18F-FLT: Undergo 18F-FLT PET/CT PET: Undergo 18F-FLT PET/CT |
| |
| Secondary | %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery | Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome. | Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1-3 LN metastases and 9 with >3 LN metastases | Posted | | Mean | Standard Deviation | percent change in SUVmax from FLT1-FLT2 | | Baseline (FLT-1) and Early Therapy (FLT-2) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |
| Secondary | %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery | %change in SUVmax from FLT1-FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1-FLT3 will be consider the outcome. | Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1-3 LN metastases and 6 with >3 LN metastases | Posted | | Mean | Standard Deviation | percent change in SUVmax from FLT1-FLT3 | | Baseline (FLT-1) and post-NAC (FLT-3) | | | | ID | Title | Description |
|---|
| OG000 | Diagnostic (18F-FLT) | Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy. Fluorothymidine F-18: Undergo 18F-FLT PET/CT Positron Emission Tomography: Undergo 18F-FLT PET/CT Computed Tomography: Undergo 18F-FLT PET/CT Laboratory Biomarker Analysis: Correlative studies |
| |