Hypoxia Imaging Techniques for Soft Tissue Sarcoma

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: The Hospital for Sick Children

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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.

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 data supports the effectiveness of the treatment 18F-FAZA, BOLD MRI, DW MRI, and MRS for soft tissue sarcoma?

Research shows that advanced MRI techniques like diffusion-weighted imaging (DW MRI) and magnetic resonance spectroscopy (MRS) can help differentiate between benign and malignant tumors, and BOLD MRI can assess changes in tumor oxygenation, which is important for treatment planning. These imaging methods are valuable in understanding tumor characteristics and could potentially improve treatment outcomes for soft tissue sarcoma. ^{1 2 3 4 5}

Is hypoxia imaging using techniques like 18F-FAZA, BOLD MRI, DW MRI, and MRS safe for humans?

The research articles do not provide specific safety data for these imaging techniques in humans, but they are commonly used in clinical settings, suggesting a general acceptance of their safety. However, it's always important to discuss any concerns with your healthcare provider before participating in a clinical trial. ^{1 6 7 8 9}

How does the hypoxia imaging treatment for soft tissue sarcoma differ from other treatments?

This treatment uses advanced imaging techniques like diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI) to assess tumor oxygen levels, which can help tailor treatments to increase tumor oxygenation and improve outcomes. Unlike standard treatments, it focuses on noninvasively measuring and optimizing the tumor's response to oxygenation therapies, potentially enhancing the effectiveness of other treatments like radiation. ^{1 2 3 5 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Added-value of advanced magnetic resonance imaging to conventional morphologic analysis for the differentiation between benign and malignant non-fatty soft-tissue tumors. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Soft tissue sarcoma: correlation of dynamic contrast-enhanced magnetic resonance imaging features with HIF-1α expression and patient outcomes. [2022]

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

Whole-tumor histogram analysis of diffusion-weighted imaging and dynamic contrast-enhanced MRI for soft tissue sarcoma: correlation with HIF-1alpha expression. [2023]

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

Detection of soft-tissue sarcoma recurrence: added value of functional MR imaging techniques at 3.0 T. [2022]

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

Using high spectral and spatial resolution bold MRI to choose the optimal oxygenating treatment for individual cancer patients. [2019]

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

Comparison of ferumoxytol- and gadolinium chelate-enhanced MRI for assessment of sarcomas in children and adolescents. [2021]

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

Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy. [2015]

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

Validation of the fluorinated 2-nitroimidazole SR-4554 as a noninvasive hypoxia marker detected by magnetic resonance spectroscopy. [2019]

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

Examining correlations of oxygen sensitive MRI (BOLD/TOLD) with [18F]FMISO PET in rat prostate tumors. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Soft tissue sarcomas: IVIM and DKI correlate with the expression of HIF-1α on direct comparison of MRI and pathological slices. [2021]