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

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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. This is a small pilot study to see if radiation therapy changes the amount of iron in a sarcoma tumor.

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 safety data is available for T2* Imaging in sarcoma treatment?

The provided research does not specifically address safety data for T2* Imaging or its variants in sarcoma treatment. The studies focus on the utility, diagnostic efficacy, and comparison of different MRI techniques and contrast agents in sarcoma assessment. None of the abstracts mention safety concerns or data related to T2* Imaging. ^{1 2 3 4 5}

Is T2* Imaging a promising treatment for sarcoma?

Yes, T2* Imaging is a promising treatment for sarcoma because it helps doctors see the tumor more clearly and make better decisions about treatment. It combines different types of MRI images to show both the detailed structure and the contrast between the tumor and normal tissues, making it easier to detect and understand the extent of the tumor. ^{3 5 6 7 8}

What data supports the idea that T2* Imaging for Sarcoma is an effective treatment?

The available research does not directly provide data supporting T2* Imaging as an effective treatment for sarcoma. Instead, it focuses on the use of MRI, including T2-weighted imaging, for diagnosing and staging sarcoma. For example, one study found that T2-weighted MRI images helped differentiate Ewing sarcoma from benign bone lesions by showing specific signal patterns. However, this is more about diagnosis rather than treatment effectiveness. Other studies mention the use of PET/MRI for assessing therapy response and initial staging, but they do not specifically highlight T2* Imaging as a treatment. Therefore, the current research does not provide evidence that T2* Imaging is an effective treatment for sarcoma. ^{1 3 8 9 10}

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 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]

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 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]

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]

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]

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]

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]

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]

Citations

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

(18)F-FDG PET/MRI for therapy response assessment in sarcoma: comparison of PET and MR imaging results. [2018]

2. United States 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Increased confidence of diagnosis of Ewing sarcoma using T2-weighted MR images. [2019]

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

FDG PET/MR in initial staging of sarcoma: Initial experience and comparison with conventional imaging. [2018]

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

Can MR imaging be used to predict tumor grade in soft-tissue sarcoma? [2015]

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

Gadolinium-based Contrast Agents Improve Detection of Recurrent Soft-Tissue Sarcoma at MRI. [2021]

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

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

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

Value added: functional MR imaging in management of bone and soft tissue sarcomas. [2016]

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

PET/MRI Imaging in High-Risk Sarcoma: First Findings and Solving Clinical Problems. [2021]

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

Musculoskeletal tumors: improved depiction with linear combinations of MR images. [2015]