Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)Early Phase 1NCT01825902
18F-FLT Positron Emission Tomography and Diffusion-Weighted Magnetic Resonance Imaging in Planning Surgery and Radiation Therapy and Measuring Response in Patients With Newly Diagnosed Ewing Sarcoma
A Early Phase 1 study testing fluorine F 18 fluorothymidine, fludeoxyglucose F 18 and positron emission tomography in people with Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) and Ewing Sarcoma of Bone, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma
- What is being tested?
- fluorine F 18 fluorothymidine, fludeoxyglucose F 18 and positron emission tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 23 Nov 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish correlation between 18F-FLT positron emission tomography (PET) activity, apparent diffusion coefficients (ADC) values from diffusion-weighted magnetic resonance imaging (DW-MRI), fludeoxyglucose F 18 (18F-FDG) PET activity, magnetic resonance imaging (MRI) contrast enhancement, and pathologic response for Ewing sarcoma.
II. Assess the efficacy of detecting therapy induced changes in 18F-FLT PET uptake and ADC from DW-MRI for more accurately predicting local control, event-free survival, and overall survival as compared to standard prognostic factors (e.g. change in tumor size).
III. Compare radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI information to delineation with pre-chemotherapy conventional MRI to determine role of advanced imaging in radiotherapy treatment planning for Ewing sarcoma.
SECONDARY OBJECTIVES:
- Establish correlation between 18F-FLT PET activity, ADC values from DW-MRI, 18F-FDG PET activity, MRI contrast enhancement, and biomolecular assays for Ewing sarcoma.
II. Determine imaging thresholds to discriminate between viable and necrotic tumor, as established through pathologic correlations.
III. Assess efficacy of advanced imaging for more accurately guiding biopsy targeting by comparing planned targeting with standard (MRI contrast enhancement) vs. advanced imaging (18F -FLT PET and DW-MRI).
IV. Compare post-treatment response assessment with 18F-FLT PET and DW-MRI vs. 18F-FDG PET to determine whether 18F-FLT PET and ADC information is more accurate than 18F-FDG PET for distinguishing between necrosis and non-specific inflammation immediately following treatment.
- Estimate potential reduction in acute and late side effects based on modified radiation therapy (RT) treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI information as compared to volumes delineated with pre-chemotherapy conventional MRI.
VI. Evaluate automatic image segmentation techniques for 18F-FLT PET and DW-MRI, comparing against biopsy determined imaging thresholds and expert Nuclear Medicine and MR Radiologist contours.
OUTLINE:
Patients undergo 18F-FLT PET, 18F-FDG PET, and DW-MRI the week prior to induction therapy, within one week after the completion of induction therapy, the week prior to RT (for patients that received surgery), and within 1 week of completion of RT.
After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 years.
- Conditions
- Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma, Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
- Being tested
- fluorine F 18 fluorothymidine, fludeoxyglucose F 18, positron emission tomography, diffusion-weighted magnetic resonance imaging, laboratory biomarker analysis
- Medical subject headings
- Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorine F 18 fluorothymidineDrug
Also called 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F-18
Undergo 18F-FLT PET
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo 18F-FDG PET
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo 18F-FLT PET and 18F-FDG PET
diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
Undergo DW-MRI
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) | Experimental | Patients undergo 18F-FLT PET, 18F-FDGPET, and DW-MRI the week prior to induction therapy, within one week after the completion of induction therapy, the week prior to RT (for patients that received surgery), and within 1 week of completion of RT. Receives: Drug: fluorine F 18 fluorothymidine; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: diffusion-weighted magnetic resonance imaging; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgical resection
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.
Measured: At the time of surgical resection
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.
Measured: At the time of surgical resection
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.
Measured: At the time of surgical resection
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.
Measured: At the time of surgical resection
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Secondary outcomes (6)
Imaging thresholds
Imaging thresholds to discriminate between > 90% and 100% necrotic tumor as established by pathology will be determined.
Measured: Up to 1 week after completion of chemotherapy and radiation therapy
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
Measured: At the time of surgery/biopsy
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.
Measured: Up to 5 years
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.
Measured: Within 7 days after completion of RT
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completion23 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia N. Laack, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825902
- Sponsor's protocol ID
- MC1279
- Other IDs
- NCI-2013-00707
- Status last verified
- Mar 2016
- First submitted
- 3 Apr 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01825902
- Acronym / sponsor ID
- MC1279
- Conditions
- Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma, Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- 23 Nov 2015 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Establish correlation between 18F-FLT positron emission tomography (PET) activity, apparent diffusion coefficients (ADC) values from diffusion-weighted magnetic resonance imaging (DW-MRI), fludeoxyglucose F 18 (18F-FDG) PET activity, magnetic resonance imaging (MRI) contrast enhancement, and pathologic response for Ewing sarcoma.
II. Assess the efficacy of detecting therapy induced changes in 18F-FLT PET uptake and ADC from DW-MRI for more accurately predicting local control, event-free survival, and overall survival as compared to standard prognostic factors (e.g. change in tumor size).
III. Compare radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI information to delineation with pre-chemotherapy conventional MRI to determine role of advanced imaging in radiotherapy treatment planning for Ewing sarcoma.
SECONDARY OBJECTIVES:
- Establish correlation between 18F-FLT PET activity, ADC values from DW-MRI, 18F-FDG PET activity, MRI contrast enhancement, and biomolecular assays for Ewing sarcoma.
II. Determine imaging thresholds to discriminate between viable and necrotic tumor, as established through pathologic correlations.
III. Assess efficacy of advanced imaging for more accurately guiding biopsy targeting by comparing planned targeting with standard (MRI contrast enhancement) vs. advanced imaging (18F -FLT PET and DW-MRI).
IV. Compare post-treatment response assessment with 18F-FLT PET and DW-MRI vs. 18F-FDG PET to determine whether 18F-FLT PET and ADC information is more accurate than 18F-FDG PET for distinguishing between necrosis and non-specific inflammation immediately following treatment.
- Estimate potential reduction in acute and late side effects based on modified radiation therapy (RT) treatment volumes with pre- and post-chemotherapy 18F-FLT PET and DW-MRI information as compared to volumes delineated with pre-chemotherapy conventional MRI.
VI. Evaluate automatic image segmentation techniques for 18F-FLT PET and DW-MRI, comparing against biopsy determined imaging thresholds and expert Nuclear Medicine and MR Radiologist contours.
OUTLINE:
Patients undergo 18F-FLT PET, 18F-FDG PET, and DW-MRI the week prior to induction therapy, within one week after the completion of induction therapy, the week prior to RT (for patients that received surgery), and within 1 week of completion of RT.
After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) | Experimental | Drug: fluorine F 18 fluorothymidine, Radiation: fludeoxyglucose F 18, Procedure: positron emission tomography, Procedure: diffusion-weighted magnetic resonance imaging, Other: laboratory biomarker analysisPatients undergo 18F-FLT PET, 18F-FDGPET, and DW-MRI the week prior to induction therapy, within one week after the completion of induction therapy, the week prior to RT (for patients that received surgery), and within 1 week of completion of RT. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorine F 18 fluorothymidineAlso: 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F-18Undergo 18F-FLT PET | Drug | Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) |
| fludeoxyglucose F 18Also: 18FDG, FDGUndergo 18F-FDG PET | Radiation | Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo 18F-FLT PET and 18F-FDG PET | Procedure or surgery | Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) |
| diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRIUndergo DW-MRI | Procedure or surgery | Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) |
| laboratory biomarker analysisCorrelative studies | Other | Diagnostic (18F-FLT PET, 18F-FDG PET, DW-MRI) |
Primary outcome
18F-FLT PET activity
Time frame: At the time of surgical resection
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.
ADC values from DW-MRI
Time frame: At the time of surgical resection
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.
18F-FDG PET activity
Time frame: At the time of surgical resection
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.
MRI contrast enhancement
Time frame: At the time of surgical resection
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.
Pathologic response
Time frame: At the time of surgical resection
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.
18F-FLT PET and DW-MRI in predicting local control, event-free survival, and overall survival, measured by therapy-induced changes in the scans
Time frame: Up to 5 years
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.
Radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI
Time frame: Up to 5 years
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.
6 secondary outcomes
Imaging thresholds
Time frame: Up to 1 week after completion of chemotherapy and radiation therapy
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
Time frame: At the time of surgery/biopsy
Accuracy in distinguishing between necrosis and non-specific inflammation immediately following treatment
Time frame: Up to 5 years
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
Time frame: Within 7 days after completion of RT
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
Time frame: Up to 5 years
Automatic image segmentation techniques for 18F-FLT PET and DW-MRI
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia N. Laack, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing fluorine F 18 fluorothymidine, fludeoxyglucose F 18 and positron emission tomography in people with Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) and Ewing Sarcoma of Bone, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-FLT PET activity (time frame: At the time of surgical resection). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.