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PET Imaging for Bladder Cancer (PET MUSE Trial)
N/A
Waitlist Available
Led By Nicholas Power, MD
Research Sponsored by Ontario Clinical Oncology Group (OCOG)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women with newly diagnosed muscle-invasive high grade urothelial carcinoma of the bladder (TNM stage T2a-T4a, N0-3, M0), who are eligible for either radical cystectomy or radiotherapy-based bladder conservation
Be older than 18 years old
Must not have
Prior partial cystectomy
History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether PET-CT can improve the accuracy of staging for bladder cancer, which could lead to better treatment and outcomes.
Who is the study for?
This trial is for adults with newly diagnosed muscle-invasive bladder cancer, who can undergo surgery or radiation. They should be aiming for curative treatment and able to lie still for imaging tests. It's not suitable for those under 18, very ill (ECOG >2), pregnant, breastfeeding, have poor liver function, had major pelvic surgery or another invasive cancer in the last 5 years.
What is being tested?
The study is testing if a whole-body PET-CT scan using FDG (a radioactive glucose compound) can better stage bladder cancer compared to standard CT scans. This could lead to more tailored treatments like extended lymph node removal or pre-surgery chemotherapy.
What are the potential side effects?
While the document doesn't list specific side effects of FDG PET-CT, common ones include discomfort from lying still during the scan and potential allergic reactions to the FDG tracer. There's also exposure to low levels of radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a new diagnosis of a serious bladder cancer and am eligible for major surgery or radiation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had part of my bladder surgically removed.
Select...
I have not had any cancer besides non-melanoma skin cancer in the last 5 years.
Select...
My liver tests are within normal limits.
Select...
More than half of my cancer cells are not urothelial carcinoma.
Select...
I need considerable assistance and cannot care for myself.
Select...
I cannot lie on my back for a PET-CT scan.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment received
Secondary study objectives
Disease-free survival
Health economic analysis
Overall survival
+1 moreOther study objectives
Change in planned management
Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Whole-body FDG PET-CTExperimental Treatment1 Intervention
Whole-body FDG PET-CT (Experimental arm)
Group II: No PET-CTActive Control1 Intervention
No PET-CT (Control arm)
Find a Location
Who is running the clinical trial?
Ontario Clinical Oncology Group (OCOG)Lead Sponsor
64 Previous Clinical Trials
41,795 Total Patients Enrolled
Cancer Care OntarioOTHER
16 Previous Clinical Trials
91,741 Total Patients Enrolled
Nicholas Power, MDPrincipal InvestigatorLHSC-Victoria Hospital
1 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had part of my bladder surgically removed.You should not have FDG PET-CT due to health reasons.I have not had any cancer besides non-melanoma skin cancer in the last 5 years.My liver tests are within normal limits.I have a new diagnosis of a serious bladder cancer and am eligible for major surgery or radiation.More than half of my cancer cells are not urothelial carcinoma.I need considerable assistance and cannot care for myself.I've had pelvic surgery that affects lymph node removal.I am being considered for a treatment aimed at curing my condition.I cannot lie on my back for a PET-CT scan.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: No PET-CT
- Group 2: Whole-body FDG PET-CT
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.
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