Pre-Surgical PET MRI Scan for Retroperitoneal Sarcoma

(PET-RPS Trial)

Overseen By Harini Suraweera, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Recurrent tumour, Second active cancer, others

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

Compensation: Varies

Number of Visits: 10

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the use of PET MRI scans to predict how well a rare cancer called retroperitoneal sarcoma responds to chemotherapy before surgery. Researchers aim to determine if PET imaging can reveal early tumor changes, enabling doctors to adjust the treatment plan sooner if necessary. The trial seeks participants with a specific type of untreated retroperitoneal sarcoma who are eligible for chemotherapy and surgery and have not received prior cancer treatment in the abdomen or pelvis. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to more personalized treatment strategies.

What prior data suggests that this PET MRI scan is safe for patients with retroperitoneal sarcoma?

Research has shown that PET MRI scans are generally safe and manageable for patients. One study found that PET MRI can detect returning soft tissue sarcomas, a type of cancer, more effectively than MRI alone. This indicates that PET MRI is reliable and poses no major risks for patients. Another study discovered that PET MRI was more accurate than PET CT in many cancer cases, achieving a high accuracy rate of 97.3%. This suggests the technology is both effective and safe for cancer imaging. No specific reports have linked negative effects directly to PET MRI scans, which is reassuring for those considering this imaging as part of a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET MRI scans for retroperitoneal sarcoma because this imaging technique offers a more detailed view of both the structure and function of tumors. Unlike the standard PET-CT scans, which primarily give structural information, PET MRI provides better soft tissue contrast and can help distinguish between different types of tissues more accurately. This could lead to better treatment planning by providing clearer insights into the tumor's characteristics and response to chemotherapy, potentially improving patient outcomes.

What evidence suggests that PET MRI is effective for assessing early response to treatment in retroperitoneal sarcoma?

Research has shown that PET scans effectively assess how retroperitoneal sarcoma (RPS) responds to treatment. Some studies found that PET scans excel at detecting cancer cells in RPS patients, enabling early detection. In this trial, participants will undergo a PET-MR scan, which combines PET with MRI, at baseline and after one chemotherapy cycle. This approach is being tested as a potentially faster and more effective way to monitor RPS response to chemotherapy compared to traditional imaging methods like CT scans. PET scans are already used for other cancer types to evaluate treatment effectiveness before changes appear in regular scans. This early detection helps doctors quickly adjust treatment plans, potentially improving patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Carol Swallow, MD, PhD

Principal Investigator

Sinai Health System

Are You a Good Fit for This Trial?

Adults over 18 with a specific type of large abdominal cancer called high-grade Retroperitoneal Sarcoma (RPS), who haven't had previous treatments. They must have a single tumor that's operable and suitable for chemotherapy, good overall health without serious heart, kidney, liver or blood conditions, no other cancers in the last 5 years except certain skin or cervical cancers, and be able to follow the study plan.

Inclusion Criteria

My cancer is a soft tissue sarcoma located below my stomach or in my pelvis.

My kidney function is normal, and the kidney not affected by my sarcoma works well.

I haven't had any cancer in the last 5 years, except for skin or early cervical cancer.

Exclusion Criteria

I have another active cancer besides the one being studied.

impossible to ensure adequate follow up

I have a non-cancerous tumor in the back of my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

PET-MR and PET-CT scans are performed to establish baseline measurements

1 week

1 visit (in-person)

Chemotherapy Treatment

Participants receive ifosfamide/doxorubicin chemotherapy every 3 weeks for 5-6 cycles

15-18 weeks

5-6 visits (in-person)

PET-MR Assessment

PET-MR scan is performed after 1 cycle of chemotherapy to assess early response

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PET MRI scan

Trial Overview The trial is testing if PET MRI scans can detect early responses to preoperative chemotherapy in patients with RPS better than conventional CT scans. This could allow doctors to adjust treatment plans sooner for better outcomes.

How Is the Trial Designed?

Group I: PET-MR arm Experimental Treatment 1 Intervention

Every eligible patient will be scanned by PET-MR at baseline and following 1 cycle of chemotherapy. PET-CT at baseline will also be obtained as it is the current standard of care and will be used to determine trial eligibility (no evidence metastasis at baseline).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798311006603

Value of PET scan in patients with retroperitoneal sarcoma ... A malignant diagnosis was confirmed in all patients who underwent CT-guided core biopsy; a diagnosis of sarcoma was reached in 91%. Sensitivity of FDG-PET ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10252049/

CT and MR Imaging of Retroperitoneal Sarcomas This article provides an overview of the current knowledge regarding cross-sectional imaging features of patients with retroperitoneal sarcomas.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04224948

NCT04224948 | The PET- Retroperitoneal Sarcoma Study This study will focus on improving the outcomes of surgery by treating RPS before surgery, to make resection more effective.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.868823/full

The Role of Preoperative 18F-fluorodeoxyglucose Positron ... In retroperitoneal sarcoma (RPS), the effectiveness of PET was not well known. ... Outcomes Following Extended Surgery for Retroperitoneal Sarcomas: Results ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22154883/

Value of PET scan in patients with retroperitoneal sarcoma ... A malignant diagnosis was confirmed in all patients who underwent CT-guided core biopsy; a diagnosis of sarcoma was reached in 91%. Sensitivity of FDG-PET ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5836919/

Imaging in retroperitoneal soft tissue sarcoma - PMC Core needle biopsy of a retroperitoneal sarcoma (RPS) is safe, reliable and must be strongly recommended unless the imaging is pathognomonic of a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0748798316310101

Primary retroperitoneal soft tissue sarcoma: Imaging ... Failure to recognise retroperitoneal sarcomas on imaging can lead to inappropriate management in inexperienced centres. This can have catastrophic consequences ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6032526/

Applications of PET-MRI in Musculoskeletal Disease - PMC Integrated PET-MRI has been recently shown to have benefit compared to MRI alone for the identification of locally recurrent soft tissue sarcomas. In a study of ...

9. mdpi.com mdpi.com/2075-4418/5/3/333

PET/MRI in Oncological Imaging: State of the Art PET/MRI is a promising new modality which may replace PET/CT in selected cancer scenarios and may generate new oncological applications.

10. link.springer.com link.springer.com/article/10.1007/s00259-019-04452-y

PET/MRI versus PET/CT in oncology: a prospective single- ... PET/MRI was accurate in 319/330 examinations and PET/CT in 277/330 examinations; the respective accuracies of 97.3% and 83.9% differed ...