T2* Imaging for Sarcoma

Overseen By Heather Brown, RN, BAN, OCN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bryan Allen

Disqualifiers: Under 18

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how radiation therapy affects iron levels in sarcoma tumors. Sarcoma is a cancer that affects tissues such as bones or muscles. T2* imaging, a type of magnetic resonance imaging with T2* weighting, assesses changes in iron levels before and after radiation therapy, potentially improving treatment outcomes. Individuals with sarcoma scheduled for radiation therapy soon after surgery or biopsy may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in sarcoma treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that T2* Imaging is safe for use in sarcoma patients?

Research has shown that T2* imaging is generally easy for patients to handle. This method helps doctors check iron levels in tumor cells. It is non-invasive, meaning it doesn't involve surgery or entering the body. T2* imaging resembles other MRI scans, which are known to be safe and carry very low risk.

No reports of major side effects specific to T2* imaging exist. MRI scans are usually safe for most people, although some might feel uncomfortable due to the noise or the small space inside the MRI machine. Importantly, T2* imaging does not use radiation, avoiding the associated risks. Overall, studies suggest that T2* imaging is a safe choice for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about T2* Imaging for sarcoma because it offers a non-invasive way to evaluate tumor oxygenation levels before and after radiation therapy. Unlike traditional imaging techniques, T2* MRI provides detailed insights into how well the tumor is responding to treatment, potentially allowing for more personalized and effective therapy plans. This innovative approach could lead to better outcomes by helping doctors adapt treatment strategies based on real-time data about the tumor's environment.

What evidence suggests that T2* Imaging is effective for identifying labile iron pools in sarcoma?

Research has shown that T2* imaging, which participants in this trial will undergo, can detect specific iron deposits in tumor cells. These iron deposits might help predict the effectiveness of certain treatments. Previous studies found that T2* imaging reliably monitors bone tumors called osteosarcomas. This method could be useful for detecting and evaluating tumors in a specific way. While direct evidence on improving sarcoma treatment outcomes is still being gathered, this imaging technique appears promising for understanding tumor behavior. ^{1 5 6 7 8}

Who Is on the Research Team?

Bryan Allen, MD, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults with pathologically confirmed Sarcoma who are prescribed radiation therapy. They should be able to perform daily activities (ECOG 0, 1, or 2) and must consent to participate. Treatment should start within five weeks after surgery or biopsy.

Inclusion Criteria

I can take care of myself and perform daily activities.

Ability and willingness to provide informed consent

My sarcoma diagnosis was confirmed through a biopsy or surgery.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo T2* MRI imaging before beginning their course of radiation therapy

1 week

1 visit (in-person)

Radiation Therapy

Participants receive radiation therapy to potentially alter iron levels in the sarcoma tumor

6 weeks

Post-Radiation Imaging

Participants undergo T2* MRI imaging after completing radiation therapy, about 2 weeks before their surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in iron levels and overall safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• T2* Imaging

Trial Overview

The study is testing T2* MRI imaging on sarcoma tumors to see if radiation therapy affects the iron levels in these tumors. It's a small pilot study designed to explore this potential relationship.

How Is the Trial Designed?

Group I: T2* Imaging Experimental Treatment 1 Intervention

Participants undergo T2\* MRI imaging before beginning their course of radiation therapy and then after completing radiation therapy, about 2 weeks before their surgery.

Who Is Running the Clinical Trial?

Bryan Allen

Lead Sponsor

Trials

4

Recruited

130+

Holden Comprehensive Cancer Center

Collaborator

Trials

27

Recruited

710+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 29 patients with sarcoma, positron emission tomography/magnetic resonance imaging (PET/MR) using 18F-fluordeoxyglucose (FDG) demonstrated excellent agreement with conventional imaging methods (CT and MR) for initial staging, with a perfect kappa value of 1 for T and M stages.

For N staging, PET/MR was identical to conventional imaging in 28 out of 29 patients, indicating high reliability, and a kappa value of 0.65 suggests good agreement overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDG PET/MR in initial staging of sarcoma: Initial experience and comparison with conventional imaging. Platzek, I., Beuthien-Baumann, B., Schramm, G., et al.[2018]

In a study of 95 patients with soft-tissue sarcoma (STS), specific MRI features such as tumor size greater than 5 cm, poorly defined margins, and heterogeneous signal intensity were found to effectively differentiate high-grade STS from low-grade STS.

The presence of peritumoral contrast enhancement was identified as the strongest independent predictor of high-grade STS, with an odds ratio of 13.6, suggesting it could be a key feature for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can MR imaging be used to predict tumor grade in soft-tissue sarcoma? Zhao, F., Ahlawat, S., Farahani, SJ., et al.[2015]

Advanced MRI techniques, such as chemical-shift MRI and diffusion-weighted imaging (DWI), enhance the ability to differentiate between benign and malignant tumors and assess treatment responses in bone and soft tissue sarcomas.

Dynamic contrast-enhanced (DCE) MRI provides valuable insights into treatment efficacy that traditional size-based assessments may miss, making it a crucial tool for evaluating sarcoma management throughout patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value added: functional MR imaging in management of bone and soft tissue sarcomas. Subhawong, TK., Wilky, BA.[2016]

In a study of 69 patients with recurrent soft-tissue sarcoma, the use of gadolinium-based contrast agents significantly improved the sensitivity of MRI for detecting tumors, with the highest sensitivity observed in the group that included both pre- and post-contrast fat-saturated T1- and fat-suppressed T2-weighted images (74%).

The addition of fat-saturated T2-weighted images to the MRI protocol provided a modest improvement in sensitivity compared to using only pre- and post-contrast T1-weighted images, highlighting the importance of using contrast agents for better diagnostic performance in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-based Contrast Agents Improve Detection of Recurrent Soft-Tissue Sarcoma at MRI. Amini, B., Murphy, WA., Haygood, TM., et al.[2021]

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]

The study developed a hybrid magnetic resonance (MR) image that combines T1- and T2-weighted images, enhancing the contrast between tumors and surrounding normal tissues, which is crucial for accurate diagnosis.

Using a 1-T MR imager, the hybrid images provided both high signal-to-noise ratios and clear anatomical details, making it easier to assess the extent of bone tumors compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal tumors: improved depiction with linear combinations of MR images. Levin, DN., Herrmann, A., Spraggins, T., et al.[2015]

In a study of 24 patients, including 18 with confirmed Ewing sarcoma, MRI showed that Ewing sarcomas typically present as homogeneous T2-weighted signals isointense with fat, which helps distinguish them from benign lesions.

The presence of associated soft tissue masses was a key feature in identifying Ewing sarcoma, as all cases had this characteristic, while only one benign lesion did, indicating that MRI can be a useful tool in diagnosing this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased confidence of diagnosis of Ewing sarcoma using T2-weighted MR images. Hanna, SL., Fletcher, BD., Kaste, SC., et al.[2019]

Magnetic resonance imaging (MR) is highly effective for local staging of soft-tissue sarcoma, with excellent interobserver agreement for tumor staging and osseous invasion, making it a reliable tool for preoperative assessment.

The study found that if the tumor contacts arteries, veins, or nerves at angles greater than 180°, it indicates significant encasement, with high sensitivity and specificity for diagnosing such encasement, which is crucial for surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Staging of Soft-Tissue Sarcoma: Emphasis on Assessment of Neurovascular Encasement-Value of MR Imaging in 174 Confirmed Cases. Holzapfel, K., Regler, J., Baum, T., et al.[2022]

In a study of 12 sarcoma patients, combined FDG PET/MRI imaging was used to assess treatment response after chemotherapy, revealing that half of the patients had stable disease and half had partial remission.

The results indicated that the response assessment using Choi criteria based on MRI showed only a slight correlation with FDG PET imaging, suggesting that these imaging techniques may provide different insights into treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-FDG PET/MRI for therapy response assessment in sarcoma: comparison of PET and MR imaging results. Schuler, MK., Platzek, I., Beuthien-Baumann, B., et al.[2018]

The simultaneous PET/MRI imaging technique provides a powerful tool for diagnosing and treating soft-tissue sarcomas (STS) by combining metabolic and structural imaging, which is particularly beneficial for soft tissue evaluation.

Preliminary data from three cases suggest that PET/MRI can enhance clinical decision-making in STS treatment, offering valuable insights that could improve patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/MRI Imaging in High-Risk Sarcoma: First Findings and Solving Clinical Problems. Schuler, MK., Richter, S., Beuthien-Baumann, B., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

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Reproducibility and repeatability of quantitative T2 and ...

Our results demonstrated high repeatability and reproducibility of quantitative T2* and T2 mapping for monitoring the presence of TAMs in osteosarcomas.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03658343

Study Details | NCT03658343 | T2* MRI Analysis for Sarcoma

T2* imaging is a method to identify labile iron pools in tumor cells. These iron pools may be linked to better treatment outcomes for specific types of therapy.

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MRI Fat-Saturated T2-Weighted Radiomics Model for ...

Background: Ki-67 expression has been shown to be an important risk factor associated with prognosis in patients with soft tissue sarcomas (STSs) ...

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pmc.ncbi.nlm.nih.gov

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MRI using T2*-, as well as T1- and T2-weighted images, may be useful to detect lesions and assess the extent of TSGCTs in a tissue-specific manner.

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frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.710649/full

Radiomics Analysis of Fat-Saturated T2-Weighted MRI ...

Methods: This study included 62 patients with STS of the extremities and trunk who underwent magnetic resonance imaging (MRI) before neoadjuvant radiotherapy.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5181551/

Accuracy of Various MRI Sequences in Determining ...

T1-weighted imaging was the best sequence to measure tumour margin without resulting in clinically significant underestimation or overestimation of the tumour ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39618573/

A Systematic Review and Meta-Analysis

This systematic review and meta-analysis evaluated MRI features capable of distinguishing high-grade from low-grade tumors in patients with soft tissue sarcoma.

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This review article evaluates conventional pulse sequences alongside emerging MRI innovations, highlighting their clinical applications, current limitations, ...