Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging


Condition: Muscle-invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02462239

Sponsor: Ontario Clinical Oncology Group (OCOG)

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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.
  • 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.

View trial on ClinicalTrials.gov


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