Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging (PET MUSE)
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ClinicalTrials.gov Identifier: NCT02462239 |
Recruitment Status :
Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : April 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Muscle-invasive Bladder Cancer | Other: Whole-body FDG PET-CT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 292 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging |
Actual Study Start Date : | May 6, 2016 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Whole-body FDG PET-CT
Whole-body FDG PET-CT (Experimental arm)
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Other: Whole-body FDG PET-CT
Other Name: PET-CT imaging |
No Intervention: No PET-CT
No PET-CT (Control arm)
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Being considered for treatment of curative intent.
Exclusion Criteria:
- Age < 18 years.
- ECOG performance status >2.
- Predominant histology (>50% of specimen) involves non-urothelial cell carcinoma.
- Prior partial cystectomy.
- Prior pelvis surgery that obviates a completed extended lymphadenectomy (e.g., aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised.
- Contraindications to FDG PET-CT.
- Inability to lie supine for imaging with PET-CT.
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Inadequate hepatic function:
(i) Bilirubin >1.5 X ULN and (ii) SGOT and Alkaline phosphatase >3 X ULN
- History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer.
- Known pregnancy or lactating female.
- Inability to complete the study or required follow-up.

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
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Hospital Regional Cancer Centre | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Thunder Bay Regional Health Sciences Centre | |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
Sunnybrook Odette Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada, M5G 2M9 |
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) |
Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT02462239 |
Other Study ID Numbers: |
OCOG-2013-PETMUSE |
First Posted: | June 4, 2015 Key Record Dates |
Last Update Posted: | April 20, 2022 |
Last Verified: | March 2022 |
Muscle-invasive bladder cancer Bladder cancer PET imaging FDG |
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |