Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging (PET MUSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02462239|
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Muscle-invasive Bladder Cancer||Other: Whole-body FDG PET-CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||291 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Whole-body FDG PET-CT
Whole-body FDG PET-CT (Experimental arm)
Other: Whole-body FDG PET-CT
Other Name: PET-CT imaging
No Intervention: No PET-CT
No PET-CT (Control arm)
- Treatment received [ Time Frame: 5 years ]For patients with planned cystectomy, treatment received includes: avoidance of planned cystectomy and node dissection, an extended (vs standard) node dissection (or standard dissection when extended is the surgeon's usual practice), use of neoadjuvant chemotherapy (vs no neoadjuvant chemotherapy). For patients with planned bladder conservation, treatment received includes: avoidance of bladder and nodal radiation (vs bladder only or no radiation) and use of neoadjuvant chemotherapy (or not).
- Disease-free survival [ Time Frame: 5 years ]Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death.
- Overall survival [ Time Frame: 5 years ]Overall survival defined by all-cause mortality.
- Quality of life analysis [ Time Frame: 5 years ]Overall QOL assessed using the EORTC QLQ-C30 version 3.
- Health economic analysis [ Time Frame: 5 years ]Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.
- Change in planned management [ Time Frame: 5 years ]Assess change in planned management with actual treatment delivered in both pre-operative PET-CT versus no PET-CT (control) patients.
- Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy [ Time Frame: 5 years ]Explore if interim response on FDG PET-CT after 2 cycles of chemotherapy is associated with clinical and pathology response to chemotherapy and if early interim metabolic response correlates with other outcome measures including DFS and OS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462239
|Contact: Marc L Filion, MSc, CCRP||905-527-2299 ext email@example.com|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Som Mukherjee, MD 905-387-9495 firstname.lastname@example.org|
|Principal Investigator: Som Mukherjee, MD|
|London Regional Cancer Centre||Recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Nick Power, MD Nicholas.Power@lhsc.on.ca|
|Principal Investigator: Eric Winquist, MD|
|Ottawa Hospital Regional Cancer Centre||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Rodney Breau, MD 613-737-8899 email@example.com|
|Principal Investigator: Rodney Breau, MD|
|Thunder Bay Regional Health Sciences Centre||Recruiting|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Contact: Dolores Sicheri, MD firstname.lastname@example.org|
|Principal Investigator: Dolores Sicheri, MD|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Susanna Cheng, MD 416-480-4928 email@example.com|
|Principal Investigator: Susanna Cheng, MD|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Srikala Sridhar, MD Srikala.Sridhar@uhn.ca|
|Principal Investigator: Srikala Sridhar, MD|
|Principal Investigator:||Srikala Sridhar, MD||Princess Margaret Hospital, Canada|
|Principal Investigator:||Nicholas Power, MD||LHSC-Victoria Hospital|
|Principal Investigator:||Som Mukherjee, MD||Juravinski Cancer Centre|
|Principal Investigator:||Ur Metser, MD||Princess Margaret Hospital, Canada|
|Study Director:||Mark Levine, MD||Ontario Clinical Oncology Group (OCOG)|