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Pre-Surgical PET MRI Scan for Retroperitoneal Sarcoma (PET-RPS Trial)
N/A
Waitlist Available
Led By Carol Swallow, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal bone marrow and hepatic function: White Blood cells ≥ 2.5 x10 9 cells/L, Platelets ≥ 80 x10 9 cells/L, Total bilirubin < 1.5 time the institutional upper limit normal of value (ULN), Adequate cardiac function: less or equal to NYHA II, Normal 12 lead ECG (without clinically significant abnormalities)
Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
PET-RPS Trial Summary
This trial will focus on improving outcomes of surgery for retroperitoneal sarcoma by treating it before surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While this trial focuses on imaging rather than drug side effects, PET MRI scans are generally safe but may include discomfort from lying still during the scan and potential allergic reactions to contrast agents used.
PET-RPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a soft tissue sarcoma located below my stomach or in my pelvis.
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My kidney function is normal, and the kidney not affected by my sarcoma works well.
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My tumor has not been treated before, except for a biopsy.
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I have not had radiation in my abdomen or pelvis for any other cancer or disease.
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My cancer is in one location, not spread to multiple spots.
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My cancer cannot be surgically removed due to its spread to major arteries or distant bones.
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I am 18 years old or older.
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My sarcoma did not start in my bones, abdomen, or reproductive organs.
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I did not have immediate surgery to remove remaining cancer after an incomplete resection.
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My surgery is not expected to leave behind visible cancer.
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I can perform light activities but not work.
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I have never had bowel obstruction, poor bowel blood supply, or severe chronic bowel inflammation.
Select...
My sarcoma is confirmed to be either Leiomyosarcoma or Dedifferentiated Liposarcoma.
PET-RPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation of PET imaging with histologic response following preoperative chemotherapy.
Secondary outcome measures
Correlation of CT imaging with histologic response, and comparing prognostic accuracy of PET-MR vs.CT imaging for histologic response, recurrence status, and survival.
PET-RPS Trial Design
1Treatment groups
Experimental Treatment
Group I: PET-MR armExperimental Treatment1 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).
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,455 Total Patients Enrolled
Carol Swallow, MD, PhDPrincipal InvestigatorSinai Health System
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have another active cancer besides the one being studied.My tumor can be removed by surgery and is suitable for chemotherapy.My tumor has not been treated before, except for a biopsy.I have not had radiation in my abdomen or pelvis for any other cancer or disease.The tumor does not spread beyond certain areas in the body, like the sciatic notch or diaphragm.My cancer is in one location, not spread to multiple spots.My cancer cannot be surgically removed due to its spread to major arteries or distant bones.I am 18 years old or older.My sarcoma did not start in my bones, abdomen, or reproductive organs.I did not have immediate surgery to remove remaining cancer after an incomplete resection.My surgery is not expected to leave behind visible cancer.I can perform light activities but not work.I have never had bowel obstruction, poor bowel blood supply, or severe chronic bowel inflammation.I have a non-cancerous tumor in the back of my abdomen.I am under 18 years old.My cancer has come back after treatment.My sarcoma is confirmed to be either Leiomyosarcoma or Dedifferentiated Liposarcoma.
Research Study Groups:
This trial has the following groups:- Group 1: PET-MR arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the sample size being utilized in this research?
"Affirmative. According to information on clinicaltrials.gov, this study is actively seeking participants after having being initially posted on October 9th 2019 and updated most recently on April 11th 2021. 35 individuals are needed from one site."
Answered by AI
Are there any open vacancies in this research project?
"Affirmative. According to information on clinicaltrials.gov, this trial is currently seeking participants with the original posting date being October 9th 2019 and the last update happening April 11th 2021."
Answered by AI
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