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

NCT02415816 | Completed

• 2 other identifiers: DWSARCNCI-2015-00290
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Sarcoma, Bone; Sarcoma, Soft Tissue; Osteosarcoma; Sarcoma, Ewing; Rhabdomyosarcoma; Non-rhabdomyosarcoma Soft-tissue Sarcoma

Keywords

Pediatric; Whole body DWI MRI

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline, at time of diagnosis (day 0 within about 5 days) to local control (up to 18 weeks)

Other Outcomes (10)

• The number of metastatic lesions detected and not detected with whole body DWI MRI, PET-CT alone and PET-CT + bone scan at the time of diagnosis of a pediatric sarcoma

  Baseline, at time of diagnosis (day 0 within about 5 days)

• The proportion of WB DWI MRIs, PET-CTs and PET-CT + bone scans that correctly identify sites of metastatic disease in patients with newly diagnosed sarcoma.

  Baseline, at diagnosis (day 0 within about 5 days)

• Primary tumor ADC values for each tumor histology group (osteosarcoma, Ewing sarcoma, non-rhabdomyosarcoma soft-tissue sarcoma and rhabdomyosarcoma (RMS)

  Baseline, at diagnosis (day 0 within about 5 days) and at protocol driven time points up to 18 weeks (time of local control).

Study Arms (1)

Participants

EXPERIMENTAL

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

Procedure: Diffusion Weighted Magnetic Resonance Imaging

Interventions

Diffusion Weighted Magnetic Resonance Imaging PROCEDURE

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

Also known as: DWI-MRI

Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Osteosarcoma; Sarcoma; Sarcoma, Ewing; Rhabdomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Myosarcoma; Neoplasms, Muscle Tissue

Study Officials

• Mary E. McCarville, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: June 5, 2015
• Primary Completion: November 19, 2019
• Study Completion: October 28, 2022
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)