Ewing Sarcoma of Bone Clinical Trial
Official title:
A Pilot Study of the Utility of 18F-FLT-PET and Diffusion-Weighted MRI for Surgical Planning, Radiotherapy Target Delineation, and Treatment Response Evaluation in Ewing Sarcoma Patients
Verified date | March 2016 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot trial studies fluorine F 18 fluorothymidine (18F-FLT) positron emission tomography and diffusion-weighted magnetic resonance imaging in planing surgery and radiation therapy and measuring response in patients with newly diagnosed Ewing sarcoma. Comparing results of diagnostic procedures done before and after treatment may help doctors predict a patient's response and help plan the best treatment.
Status | Completed |
Enrollment | 1 |
Est. completion date | November 23, 2015 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years and older |
Eligibility |
Inclusion Criteria: - Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing sarcoma (ES) or primitive neuroectodermal tumor (PNET) of bone or soft tissue - Planning to receive definitive RT or surgery with or without adjuvant RT - Willing to sign release of information for any follow-up records - Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent - Patients must have measurable disease - Willingness to participate in mandatory imaging studies - Willingness to provide mandatory pathology samples for correlative research Exclusion Criteria: - Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) - Unable to undergo 18F-FLT PET scan - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 18F-FLT PET activity | The primary measure of the samples will be % of viable malignant cells remaining. To examine the correlation of 18F-FLT PET, 18F-FDG PET, and ADC signals in areas of concordance and discordance with standard MR imaging as it impacts differentiation of viable and necrotic tumor extent, sensitivity/specificity and positive/negative predictive values will be estimated. Findings will be summarized using point-estimates and corresponding 95% confidence intervals as appropriate. Differences in sensitivity and specificity will be evaluated using McNemar's test. | At the time of surgical resection | |
Primary | ADC values from DW-MRI | The primary measure of the samples will be % of viable malignant cells remaining. To examine the correlation of 18F-FLT PET, 18F-FDG PET, and ADC signals in areas of concordance and discordance with standard MR imaging as it impacts differentiation of viable and necrotic tumor extent, sensitivity/specificity and positive/negative predictive values will be estimated. Findings will be summarized using point-estimates and corresponding 95% confidence intervals as appropriate. Differences in sensitivity and specificity will be evaluated using McNemar's test. | At the time of surgical resection | |
Primary | 18F-FDG PET activity | The primary measure of the samples will be % of viable malignant cells remaining. To examine the correlation of 18F-FLT PET, 18F-FDG PET, and ADC signals in areas of concordance and discordance with standard MR imaging as it impacts differentiation of viable and necrotic tumor extent, sensitivity/specificity and positive/negative predictive values will be estimated. Findings will be summarized using point-estimates and corresponding 95% confidence intervals as appropriate. Differences in sensitivity and specificity will be evaluated using McNemar's test. | At the time of surgical resection | |
Primary | MRI contrast enhancement | The primary measure of the samples will be % of viable malignant cells remaining. To examine the correlation of 18F-FLT PET, 18F-FDG PET, and ADC signals in areas of concordance and discordance with standard MR imaging as it impacts differentiation of viable and necrotic tumor extent, sensitivity/specificity and positive/negative predictive values will be estimated. Findings will be summarized using point-estimates and corresponding 95% confidence intervals as appropriate. Differences in sensitivity and specificity will be evaluated using McNemar's test. | At the time of surgical resection | |
Primary | Pathologic response | The primary measure of the samples will be % of viable malignant cells remaining. To examine the correlation of 18F-FLT PET, 18F-FDG PET, and ADC signals in areas of concordance and discordance with standard MR imaging as it impacts differentiation of viable and necrotic tumor extent, sensitivity/specificity and positive/negative predictive values will be estimated. Findings will be summarized using point-estimates and corresponding 95% confidence intervals as appropriate. Differences in sensitivity and specificity will be evaluated using McNemar's test. | At the time of surgical resection | |
Primary | 18F-FLT PET and DW-MRI in predicting local control, event-free survival, and overall survival, measured by therapy-induced changes in the scans | The prognostic ability of 18F-FLT PET and DW-MRI imaging will be evaluated by correlating changes in 18F-FLT uptake and ADC as treatment response both after chemotherapy (but prior to RT) and after RT with local control and survival outcomes, with the intent of establishing predictive thresholds. The results will be compared to standard prognostic factors such as change in tumor size and histopathology. | Up to 5 years | |
Primary | Radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI | PET images and DW-MRI ADC maps co-registered and regions of concordance and discordance quantified for each modality as compared to pre-chemotherapy conventional MRI. The concordance correlation coefficient will be used to measure agreement between volumes generated at different times, with different modalities, and by different individuals. The measured variability associated with contrast-enhanced MRI will serve as the standard for comparison. The mean and standard deviation of volumes and their discordances will be calculated as a measure of the potential treatment impact of each modality. | Up to 5 years | |
Secondary | Imaging thresholds | Imaging thresholds to discriminate between > 90% and 100% necrotic tumor as established by pathology will be determined. | Up to 1 week after completion of chemotherapy and radiation therapy | |
Secondary | Efficacy of advanced imaging in accurately guiding biopsy, measured by differences in determining target location by contrast enhancement or 18F-FLT PET and DW-MRI | At the time of surgery/biopsy | ||
Secondary | Accuracy in distinguishing between necrosis and non-specific inflammation immediately following treatment | Treatment response as measured by the advanced imaging immediately following treatment will be compared to response as measured by conventional 18F-FDG PET follow-up imaging. In the case of local recurrence, patterns of local failure will be compared with imaging performed before and after local therapy. | Up to 5 years | |
Secondary | Reduction in acute side effects based on modified RT treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | For each patient the portion of the treated volume that is negative on PET or DW-MRI will be calculated to estimate the region of additional normal tissue that could be excluded from radiation treatment fields. Similarly, any volume that is positive on PET or DW-MRI, but outside of the post-chemotherapy treatment volume will be reported. | Within 7 days after completion of RT | |
Secondary | Reduction in late side effects based on modified RT treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI as assessed by the NCI CTCAE 4.0 version | For each patient the portion of the treated volume that is negative on PET or DW-MRI will be calculated to estimate the region of additional normal tissue that could be excluded from radiation treatment fields. Similarly, any volume that is positive on PET or DW-MRI, but outside of the post-chemotherapy treatment volume will be reported. | Up to 5 years | |
Secondary | Automatic image segmentation techniques for 18F-FLT PET and DW-MRI | To develop a standardized delineation technique for the 18F-FLT PET and DW-MRI images and reduce operator error and subjectivity, the variation of volumes defined with different segmentation techniques will be evaluated and compared against the biopsy determined imaging thresholds and expert Nuclear Medicine and MR Radiologist contours. | Up to 5 years |
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