Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas

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Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02415816
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St. Jude Children's Research Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mary E. McCarville, MD
Principal Investigator Affiliation	St. Jude Children's Research Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoma, Bone, Sarcoma, Soft Tissue, Osteosarcoma, Sarcoma, Ewing, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft-tissue Sarcoma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Participants

All patients who consent to participate in this protocol. They will have diffusion weighted magnetic resonance imaging performed at several time points.

Interventions

Procedure: - Diffusion Weighted Magnetic Resonance Imaging

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105