DW-MRI for Sarcoma in Young Patients

Overseen By Mary E. McCarville, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Upfront resection, ICU, MRI safety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

98 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Diffusion Weighted Magnetic Resonance Imaging for sarcoma in young patients?

Research shows that Diffusion Weighted Imaging (DWI) can help assess how well a tumor is responding to cancer treatment and improve the evaluation of tumor boundaries in soft tissue sarcomas. It has also been useful in monitoring treatment response in pediatric sarcomas, indicating its potential effectiveness in managing these conditions. ^{1 2 3 4 5}

Is Diffusion Weighted MRI safe for use in humans?

Diffusion Weighted MRI (DW-MRI) is generally considered safe for use in humans, as it is a type of MRI scan that does not involve radiation and has been used in various studies to help detect and evaluate tumors in different parts of the body. ^{3 4 6 7 8}

How is DW-MRI treatment different for sarcoma in young patients?

DW-MRI (Diffusion Weighted Magnetic Resonance Imaging) is unique because it helps assess the density of tumor cells and can improve the evaluation of tumor boundaries and involvement with surrounding tissues, which is not typically possible with standard imaging techniques. This makes it particularly useful for planning treatment and monitoring response in young patients with sarcoma. ^{1 3 4 7 8}

Research Team

Mary E. McCarville, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for young patients at St. Jude with newly diagnosed bone or soft tissue sarcomas who haven't started treatment yet. They must have had or be scheduled for a PET-CT/bone scan and can undergo MRI within 2-5 days of starting therapy. It's not for those needing immediate tumor resection, ICU patients, those unable to meet MRI safety requirements, or if sedation is risky due to certain health conditions.

Inclusion Criteria

I have had or will have a PET-CT or bone scan within 2 weeks of my MRI.

My age or gender does not affect my eligibility.

Informed consent or assent signed by study subject or parent/guardian according to institutional guidelines

Exclusion Criteria

Subject does not meet institutional MRI safety screening requirements

I do not have any current heart or lung conditions that would prevent me from safely receiving sedation for an MRI.

My tumor is scheduled for surgical removal soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Whole body and primary tumor diffusion weighted imaging (DWI) performed at baseline

1 week

1 visit (in-person)

Treatment Imaging

Additional DW-MRIs performed up to 3 times during treatment at the same time as routine MRI examinations

18 weeks

Up to 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment until completion of local control

Up to 5 years

Treatment Details

Interventions

• Diffusion Weighted Magnetic Resonance Imaging

Trial Overview The study tests whether whole body diffusion weighted magnetic resonance imaging (DW-MRI), which doesn't use harmful radiation, can effectively measure tumor response in pediatric sarcoma patients compared to current methods that do use radiation.

Participant Groups

Group I: Participants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted echo-planar magnetic resonance imaging for the assessment of tumor cellularity in patients with soft-tissue sarcomas. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted magnetic resonance imaging allows monitoring of anticancer treatment effects in patients with soft-tissue sarcomas. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Soft tissue sarcoma: adding diffusion-weighted imaging improves MR imaging evaluation of tumor margin infiltration. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Diffusion weighted imaging of pediatric and adolescent malignancies with regard to detection and delineation: initial experience. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

The value of diffusion weighted imaging and apparent diffusion coefficient in primary Osteogenic and Ewing sarcomas for the monitoring of response to treatment: Initial experience. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Differentiation of malignant from benign soft tissue tumours: use of additive qualitative and quantitative diffusion-weighted MR imaging to standard MR imaging at 3.0 T. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Added value of diffusion-weighted imaging to conventional MRI for predicting fascial involvement of soft tissue sarcomas. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Value of diffusion-weighted images in differentiating mid-course responders to chemotherapy for osteosarcoma compared to the histological response: preliminary results. [2021]