Sarcoma, BoneNCT02415816
Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas
A study testing Diffusion Weighted Magnetic Resonance Imaging in people with Sarcoma, Bone and Sarcoma, Soft Tissue, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Children with sarcomas are routinely assessed with a variety of imaging techniques that involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone scan, and positron emission tomography-CT (PET-CT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma, Bone, Sarcoma, Soft Tissue, Osteosarcoma
- What is being tested?
- Diffusion Weighted Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2015to 28 Oct 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All St Jude patients with a known or suspected, newly diagnosed bone or soft-tissue sarcoma who will be treated on or as per disease specific protocols.
- Study subjects will have undergone or are scheduled for PET-CT and/or bone scan within about 2 weeks of the WB and primary tumor DWI MRI.
- No limit on age or gender
- Informed consent or assent signed by study subject or parent/guardian according to institutional guidelines.
- Patients should not have begun therapy, or, needed research imaging can be performed within 2-5 days of starting therapy.
Who cannot join
- Subject has a tumor that will undergo upfront resection
- Subject is unable or unwilling to follow study requirements, including signed consent or assent
- Subject is hospitalized in the intensive care unit.
- Subject does not meet institutional MRI safety screening requirements.
- Subject has undergone primary tumor resection prior to arrival at St. Jude.
- Subjects who require sedation for WB MRI will be excluded if they have:
- An acute cardiopulmonary process including, but not limited to, croup, reactive airways disease, pneumonia, clinical or radiological evidence of pericardial effusion or other cardiopulmonary disease.
- Vomiting within 24 hours of the MRI or substantial nausea that may preclude sedation as determined by the anesthesiologist or certified registered nurse anesthetist.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Diffusion Weighted Magnetic Resonance Imaging in Pediatric Sarcomas
Children with sarcomas are routinely assessed with a variety of imaging techniques that involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many imaging studies at the time of diagnosis, during therapy and for years following completion of therapy. Because children are in a stage of rapid growth, their tissues and organs are more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore, compared to adults, children have a longer life expectancy and, therefore, a longer period of time in which to develop the adverse sequelae of radiation exposure, such as the development of second malignancies.
Alternative experimental methods of measuring tumor response will be compared to current standard of care measures to determine if the experimental method is equivalent to methods currently being used. Investigators wish to determine if they can reduce patient's exposure to the harmful effects of ionizing radiation by replacing imaging studies that use radiation with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use any radiation. They also want to know if DW-MRI measurements of the tumor can tell how well the tumor is responding to therapy. There have been studies in adults with cancer that have shown that DW-MRI provides useful information about how tumors are responding to therapy. There have only been very small studies of DW-MRI in children with tumors in the body. Therefore, the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still experimental. This study might give us important information that could help us treat other children with bone or soft tissue sarcomas in the future.
Read the detailed description
Whole body (WB) and primary tumor diffusion weighted imaging (DWI) will be performed at baseline in all subjects. Additional DW-MRIs will be done up to 3 times during treatment at the same time as routine MRI examinations are scheduled. Follow-up primary tumor DWI MRI examinations will be performed at time points determined by the participant's therapeutic treatment protocol. Follow-up primary tumor DWI examinations will be performed until completion of local control (surgical resection or completion of radiation therapy). All examinations will be performed on 1.5T Siemens magnetic resonance (MR) scanners unless there is a clinical indication for 3T imaging.
Because investigators will correlate imaging parameters with patient outcome, participants will be followed until they are discharged to the After Completion of Therapy Clinic or until they have tumor progression or recurrence or develop a second malignancy or death, whichever comes first.
PRIMARY OBJECTIVES:
- To estimate the proportion of pediatric sarcoma patients whose bone/bone marrow and soft-tissue metastasis status are correctly staged by whole body diffusion weighted MRI (WB DWI) at the time of diagnosis by comparing it to clinical stage.
- To determine the correlation between changes in primary pediatric sarcoma 18F-fluorodeoxyglucose positron emission tomography (FDG PET) maximum standardized uptake values (SUVmax) and average DWI apparent diffusion coefficient (ADC) values from baseline (pre-treatment) to just prior to local control.
OTHER PRESPECIFIED OBJECTIVES:
- To estimate the sensitivity, specificity, accuracy, and negative and positive predictive values of WB DWI, PET-CT and PET-CT + bone scan for detecting sites of metastatic tumor in pediatric sarcomas using biopsy or clinical follow-up (including imaging studies and clinical information) as the reference standards.
- To compare the ability of WB MRI, PET-CT and PET-CT + bone scan to detect all sites of metastases in pediatric sarcoma patients using biopsy and clinical judgment as the reference standards.
- To examine the associations of DWI ADC values of primary tumors at diagnosis and treatment protocol driven time points during therapy with tumor histology, tumor grade, RECIST response, % tumor necrosis, FDG SUVmax and patient outcome.
- To compare whole body DWI to conventional T1W and STIR whole body MRI for the detection of nodal, bone/bone marrow, soft-tissue or lung metastases among pediatric bone and soft-tissue sarcoma patients using biopsy and clinical judgment as the reference standards.
- To investigate the value of a variety of quantitative parameters obtained from software analysis of the primary tumor, such as; histogram kurtosis, range, peak, shifts in peak, or tumor heterogeneity.
- Conditions
- Sarcoma, Bone, Sarcoma, Soft Tissue, Osteosarcoma, Sarcoma, Ewing, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft-tissue Sarcoma
- Being tested
- Diffusion Weighted Magnetic Resonance Imaging
- Keywords
- Pediatric, Whole body DWI MRI
- Medical subject headings
- Osteosarcoma, Sarcoma, Sarcoma, Ewing, Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Weighted Magnetic Resonance ImagingProcedure or surgery
Also called DWI-MRI
Diffusion weighted magnetic resonance imaging (DWI MRI) is a method that does not involve radiation and can be used to assess the primary tumor as well as to image the entire patient, from head to toe. Diffusion weighted MRI uses a strong motion probing gradient to detect the movement of water in tissue. Tissues that are composed of tightly packed cells, such as tumors, allow less water movement than tissues with loosely packed cells. As tumors respond to therapy they become necrotic and cells are less tightly packed. This change in water diffusivity can be quantitated using DWI. Therefore, DWI provides a non-invasive, non-ionizing, and quantitative method of assessing tumor response at a cellular level and does not depend on a change in tumor size
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | All patients who consent to participate in this protocol. They will have diffusion weighted magnetic resonance imaging performed at several time points. Receives: Procedure: Diffusion Weighted Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with pediatric sarcomas whose bone/bone marrow and soft-tissue metastasis status is correctly staged with whole body DWI MRI
To allow for blinding, reading of scan images will be delayed at least 2 months and up to 6 months following scan.
Proportion of participants whose bone/bone marrow and soft-tissue metastases were detected with whole body DWI MRI
Measured: Baseline, at time of diagnosis (day 0 within about 5 days)
The primary tumor DWI ADC and FDG PET SUVmax values at baseline and protocol driven time points up until local control
The primary tumor DWI ADC (in mm^2/sec) and FDG PET SUVmax (unitless) values at baseline and protocol driven time points up until local control.
Local control is defined as surgical resection or initiation of radiation therapy.
To allow for blinding, reading of scan images will be delayed at least 2 months and up to 6 months following scan.
Measured: Baseline, at time of diagnosis (day 0 within about 5 days) to local control (up to 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start5 Jun 2015
- Primary completion19 Nov 2019
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, BoneStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary E. McCarville, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415816
- Sponsor's protocol ID
- DWSARC
- Other IDs
- NCI-2015-00290
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2015
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted Magnetic Resonance Imaging in Pediatric Sarcomas
- ClinicalTrials.gov ID
- NCT02415816
- Acronym / sponsor ID
- DWSARC
- Conditions
- Sarcoma, Bone, Sarcoma, Soft Tissue, Osteosarcoma, Sarcoma, Ewing, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft-tissue Sarcoma
- Keywords
- Pediatric, Whole body DWI MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 14 Apr 2015 (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.
Children with sarcomas are routinely assessed with a variety of imaging techniques that involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many imaging studies at the time of diagnosis, during therapy and for years following completion of therapy. Because children are in a stage of rapid growth, their tissues and organs are more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore, compared to adults, children have a longer life expectancy and, therefore, a longer period of time in which to develop the adverse sequelae of radiation exposure, such as the development of second malignancies.
Alternative experimental methods of measuring tumor response will be compared to current standard of care measures to determine if the experimental method is equivalent to methods currently being used. Investigators wish to determine if they can reduce patient's exposure to the harmful effects of ionizing radiation by replacing imaging studies that use radiation with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use any radiation. They also want to know if DW-MRI measurements of the tumor can tell how well the tumor is responding to therapy. There have been studies in adults with cancer that have shown that DW-MRI provides useful information about how tumors are responding to therapy. There have only been very small studies of DW-MRI in children with tumors in the body. Therefore, the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still experimental. This study might give us important information that could help us treat other children with bone or soft tissue sarcomas in the future.
Detailed description
Whole body (WB) and primary tumor diffusion weighted imaging (DWI) will be performed at baseline in all subjects. Additional DW-MRIs will be done up to 3 times during treatment at the same time as routine MRI examinations are scheduled. Follow-up primary tumor DWI MRI examinations will be performed at time points determined by the participant's therapeutic treatment protocol. Follow-up primary tumor DWI examinations will be performed until completion of local control (surgical resection or completion of radiation therapy). All examinations will be performed on 1.5T Siemens magnetic resonance (MR) scanners unless there is a clinical indication for 3T imaging.
Because investigators will correlate imaging parameters with patient outcome, participants will be followed until they are discharged to the After Completion of Therapy Clinic or until they have tumor progression or recurrence or develop a second malignancy or death, whichever comes first.
PRIMARY OBJECTIVES:
- To estimate the proportion of pediatric sarcoma patients whose bone/bone marrow and soft-tissue metastasis status are correctly staged by whole body diffusion weighted MRI (WB DWI) at the time of diagnosis by comparing it to clinical stage.
- To determine the correlation between changes in primary pediatric sarcoma 18F-fluorodeoxyglucose positron emission tomography (FDG PET) maximum standardized uptake values (SUVmax) and average DWI apparent diffusion coefficient (ADC) values from baseline (pre-treatment) to just prior to local control.
OTHER PRESPECIFIED OBJECTIVES:
- To estimate the sensitivity, specificity, accuracy, and negative and positive predictive values of WB DWI, PET-CT and PET-CT + bone scan for detecting sites of metastatic tumor in pediatric sarcomas using biopsy or clinical follow-up (including imaging studies and clinical information) as the reference standards.
- To compare the ability of WB MRI, PET-CT and PET-CT + bone scan to detect all sites of metastases in pediatric sarcoma patients using biopsy and clinical judgment as the reference standards.
- To examine the associations of DWI ADC values of primary tumors at diagnosis and treatment protocol driven time points during therapy with tumor histology, tumor grade, RECIST response, % tumor necrosis, FDG SUVmax and patient outcome.
- To compare whole body DWI to conventional T1W and STIR whole body MRI for the detection of nodal, bone/bone marrow, soft-tissue or lung metastases among pediatric bone and soft-tissue sarcoma patients using biopsy and clinical judgment as the reference standards.
- To investigate the value of a variety of quantitative parameters obtained from software analysis of the primary tumor, such as; histogram kurtosis, range, peak, shifts in peak, or tumor heterogeneity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Procedure: Diffusion Weighted Magnetic Resonance ImagingAll patients who consent to participate in this protocol. They will have diffusion weighted magnetic resonance imaging performed at several time points. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All St Jude patients with a known or suspected, newly diagnosed bone or soft-tissue sarcoma who will be treated on or as per disease specific protocols.
- Study subjects will have undergone or are scheduled for PET-CT and/or bone scan within about 2 weeks of the WB and primary tumor DWI MRI.
- No limit on age or gender
- Informed consent or assent signed by study subject or parent/guardian according to institutional guidelines.
- Patients should not have begun therapy, or, needed research imaging can be performed within 2-5 days of starting therapy.
Key exclusion criteria (8 listed)
- Subject has a tumor that will undergo upfront resection
- Subject is unable or unwilling to follow study requirements, including signed consent or assent
- Subject is hospitalized in the intensive care unit.
- Subject does not meet institutional MRI safety screening requirements.
- Subject has undergone primary tumor resection prior to arrival at St. Jude.
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 |
|---|---|---|
| Diffusion Weighted Magnetic Resonance ImagingAlso: DWI-MRIDiffusion weighted magnetic resonance imaging (DWI MRI) is a method that does not involve radiation and can be used to assess the primary tumor as well as to image the entire patient, from head to toe. Diffusion weighted MRI uses a strong motion probing gradient to detect the movement of water in tissue. Tissues that are composed of tightly packed cells, such as tumors, allow less water movement than tissues with loosely packed cells. As tumors respond to therapy they become necrotic and cells are less tightly packed. This change in water diffusivity can be quantitated using DWI. Therefore, DWI provides a non-invasive, non-ionizing, and quantitative method of assessing tumor response at a cellular level and does not depend on a change in tumor size | Procedure or surgery | Participants |
Primary outcome
Proportion of participants with pediatric sarcomas whose bone/bone marrow and soft-tissue metastasis status is correctly staged with whole body DWI MRI
Time frame: Baseline, at time of diagnosis (day 0 within about 5 days)
To allow for blinding, reading of scan images will be delayed at least 2 months and up to 6 months following scan. Proportion of participants whose bone/bone marrow and soft-tissue metastases were detected with whole body DWI MRI
The primary tumor DWI ADC and FDG PET SUVmax values at baseline and protocol driven time points up until local control
Time frame: Baseline, at time of diagnosis (day 0 within about 5 days) to local control (up to 18 weeks)
The primary tumor DWI ADC (in mm^2/sec) and FDG PET SUVmax (unitless) values at baseline and protocol driven time points up until local control. Local control is defined as surgical resection or initiation of radiation therapy. To allow for blinding, reading of scan images will be delayed at least 2 months and up to 6 months following scan.
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 4 Feb 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Mary E. McCarville, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Weighted Magnetic Resonance Imaging in people with Sarcoma, Bone and Sarcoma, Soft Tissue, run by St. Jude Children's Research Hospital 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 5 inclusion and 8 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 4 Feb 2026. 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.
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?
Proportion of participants with pediatric sarcomas whose bone/bone marrow and soft-tissue metastasis status is correctly staged with whole body DWI MRI (time frame: Baseline, at time of diagnosis (day 0 within about 5 days)). The study lists 2 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 4 Feb 2026.