Hypoxia Imaging Techniques for Soft Tissue Sarcoma

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: The Hospital for Sick Children

Disqualifiers: Immunodeficiency, Sickle cell, Pulmonary, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test new imaging methods to evaluate their effectiveness in tracking treatment response in children with suspected soft tissue sarcomas, a type of cancer. It compares three advanced MRI techniques—Blood Oxygen Level Dependent (BOLD) MRI, Diffusion-Weighted (DW) MRI, and Magnetic Resonance Spectroscopy (MRS)—with standard MRI to determine which best shows changes after therapy. Additionally, the trial uses 18F-FAZA, a radiotracer, to enhance imaging results. Children and teens between 6 and 18 years old with a possible sarcoma tumor and who are set to start treatments like chemotherapy may be suitable candidates. The goal is to use these imaging results to tailor treatments to each patient's needs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in cancer imaging.

Will I have to stop taking my current medications?

The trial information 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 prior data suggests that these hypoxia imaging techniques are safe for pediatric soft tissue sarcoma patients?

Research shows that the imaging techniques used in this trial, such as BOLD MRI, DW MRI, and MRS, are generally easy for patients to handle.

Studies have found that BOLD MRI can safely predict tumor response to treatment by checking blood oxygen levels, with no serious side effects reported. Similarly, DW MRI has been used in many studies to image soft tissue tumors, with no major safety issues noted. It helps in finding and assessing tumors, and patients usually tolerate it well. MRS, which examines chemical changes in the body, is also considered safe and provides important information about tumors without significant side effects.

Since this trial is in its early stages, it mainly focuses on safety and how well patients manage these imaging techniques. The absence of adverse events in existing research and clinical use suggests that these imaging methods are likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the hypoxia imaging techniques for soft tissue sarcoma because these methods offer a non-invasive way to assess tumor oxygenation, which is crucial for treatment planning. Unlike traditional imaging methods, 18F-FAZA and BOLD MRI provide real-time insights into the tumor's oxygen levels, potentially predicting how well the tumor might respond to therapies. Additionally, Diffusion-Weighted MRI and Magnetic Resonance Spectroscopy offer detailed information on the tumor's cellular environment and metabolic profile, helping to tailor more effective treatment strategies. These advanced imaging techniques could lead to more personalized and effective treatment plans for patients with soft tissue sarcoma.

What evidence suggests that these imaging techniques are effective for detecting response to therapy in soft tissue sarcoma?

Research has shown that certain MRI techniques can help predict a tumor's response to treatment. In this trial, participants will undergo imaging with Blood Oxygen Level Dependent (BOLD) MRI, which assesses blood oxygen levels and blood vessel function to make these predictions. Diffusion-Weighted (DW) MRI, another technique in this trial, distinguishes between non-cancerous and cancerous tumors and predicts how tumors will respond to treatments like radiotherapy. Additionally, Magnetic Resonance Spectroscopy (MRS) helps understand tumor metabolism and links to treatment outcomes in patients with soft tissue sarcomas. These imaging methods reveal tumor reactions to treatment, enabling more personalized therapy plans. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 7-18 with suspected or confirmed sarcoma tumors who are candidates for standard chemotherapy, possibly with radiation. It's not suitable for those with other diagnoses, MRI contraindications like metal implants, no need for neoadjuvant therapy, immunodeficiency diseases, another cancer type, or chronic lung disease.

Inclusion Criteria

I am eligible for initial treatment with chemotherapy, possibly including radiation.

I have been diagnosed or suspected to have a sarcoma tumor with a part growing outside the bone.

Exclusion Criteria

I have a long-term lung condition.

You cannot have an MRI scan due to having metal in your body, a pacemaker, or not being able to stay still during the scan without sedation.

I have an immune system disorder, sickle cell, collagen disease, or another cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants undergo neoadjuvant therapy with imaging technologies to measure response to therapy

Varies

Regular imaging visits

Follow-up

Participants are monitored for safety and effectiveness after therapy

1 year

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FAZA
• Blood Oxygen Level Dependent [BOLD] MRI
• Diffusion-Weighted [DW] MRI
• Magnetic Resonance Spectroscopy [MRS]

Trial Overview The study tests imaging technologies to measure tumor hypoxia in pediatric soft tissue sarcomas. It compares BOLD MRI, DW MRI, MRS and 18F-FAZA PET-MRI against conventional MRI to assess response to therapy before surgery.

How Is the Trial Designed?

Group I: BOLD- DW- MRS Experimental Treatment 3 Interventions

Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI, MR Spectroscopy \[MRS\]

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

This study compared BOLD and TOLD MRI techniques with the radiotracer [18F]FMISO in tumor-bearing rats, revealing that both MRI methods can provide insights into tumor oxygenation and correlate with hypoxia levels indicated by PET imaging.

The findings suggest that regional variations in tumor oxygenation are important, as stronger correlations were found in well-perfused areas, highlighting the need for further research into the relationship between MRI signals and hypoxia in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining correlations of oxygen sensitive MRI (BOLD/TOLD) with [18F]FMISO PET in rat prostate tumors. Zhou, H., Chiguru, S., Hallac, RR., et al.[2020]

Ferumoxytol (FMX)-enhanced MRI is as effective as gadolinium (Gd)-enhanced MRI for assessing the size and features of bone and soft tissue sarcomas in pediatric and adolescent patients, based on a study of 22 patients.

FMX-MRI offers better tumor delineation and more accurate evaluation of neurovascular involvement and tumor thrombi compared to Gd-MRI, suggesting it could be a safer alternative for MRI staging in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ferumoxytol- and gadolinium chelate-enhanced MRI for assessment of sarcomas in children and adolescents. Siedek, F., Muehe, AM., Theruvath, AJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3150732/

Therapeutic Response in Musculoskeletal Soft Tissue Sarcomas This paper provides a literature review of the use of magnetic resonance imaging in monitoring the treatment response of soft tissue sarcomas (STS).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9434553/

Comparing the blood oxygen level–dependent fluctuation ... The aim of this study is to compare the blood oxygen level–dependent (BOLD) fluctuation power in 96 frequency points ranging from 0 to 0.25 Hz between benign ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0959804915011429

Evaluation of response after pre-operative radiotherapy in ... This manuscript which focuses on the use of magnetic resonance imaging (MRI) for assessing response in STS following RT is targeted at radiologists and ...

4. openaccessjournals.com openaccessjournals.com/articles/bold-mri-a-tool-for-predicting-tumor-therapy-outcome-based-on-tumor-blood-oxygenation-and-vascular-function-8163.html

BOLD MRI: a tool for predicting tumor therapy outcome based ... BOLD MRI: a tool for predicting tumor therapy outcome based on tumor blood oxygenation and vascular function

5. ajronline.org ajronline.org/doi/10.2214/AJR.12.8969

Tumoral Hypoxia in Osteosarcoma in Rats: Preliminary Study ... The aim of our study was to determine the role of blood oxygenation level–dependent (BOLD) functional MRI in an osteosarcoma rodent model by comparison of ...

6. openaccessjournals.com openaccessjournals.com/articles/bold-mri-a-tool-for-predicting-tumor-therapy-outcome-based-on-tumor-blood-oxygenation-and-vascular-function.pdf

BOLD MRI: a tool for predicting tumor therapy outcome based ... We believe that oxygen-sensitive MRI can be used to evaluate tumor hypoxia so that ther- apy may be individualized and optimized for.

7. academic.oup.com academic.oup.com/bjr/article/96/1146/20220624/7451312

T1 based oxygen-enhanced MRI in tumours; a scoping review ... The aim of this study was to identify and characterise the research into OE-MRI for characterising hypoxia in solid tumours.

8. mdpi.com mdpi.com/2072-6694/13/10/2421

Blood Oxygenation Level Dependent Magnetic Resonance ... The aim of the study is to combine blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI), dynamic contrast enhanced MRI (DCE-MRI), and ...