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: Unknown

35 Participants Needed

Trial Summary

What is the purpose of this trial?

Retroperitoneal sarcoma(RPS) is a rare cancer that is difficult to cure as it typically presents as a very large abdominal mass, and complete removal with clear margins is challenging . This study will focus on improving the outcomes of surgery by treating RPS before surgery, to make resection more effective. The role of chemotherapy as a preoperative treatment for RPS is highly controversial. Response to chemotherapy is unpredictable and if the patient's tumour progresses instead of responding, the window of opportunity for resection will be lost. Conventional cross sectional imaging (CT scan) is inadequate to measure response to chemotherapy until 5-6 cycles have been given, possibly with no improvement. Thus it is critical to develop an earlier and reliable way to assess response. Functional imaging by PET scan is used in other tumour types to identify early response to treatment. PET imaging may provide a more meaningful assessment of RPS response to systemic therapy much earlier in the course of treatment than conventional imaging, allowing timely modification of the treatment plan. This study will define the role of PET imaging in evaluating early response to systemic therapy in high grade RPS, improving patient treatment.

Research Team

Carol Swallow, MD, PhD

Principal Investigator

Sinai Health System

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+