Status:
UNKNOWN
Complete Local Response to Neoadjuvant Chemotherapy in Patients With Muscle Invasive Bladder Cancer Evaluated by 15O-H2O PET/MR
Lead Sponsor:
Jørgen Bjerggaard Jensen
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Treatment of localized muscle invasive bladder cancer (MIBC) is radical cystectomy. Neoadjuvant chemotherapy (NAC) improves survival. Approximately 50-60% of all MIBC patients undergoing NAC before c...
Detailed Description
For patients with MIBC treated with NAC and radical cystectomy there is currently no good way of evaluating whether the patient is true T0 or has remnant tumor in need for consolidating radical treatm...
Eligibility Criteria
Inclusion
- Diagnosis of MIBC stage cT2-4a.
- Preoperative PET/CT of thorax, abdomen, and pelvis with no suspicion of organ metastases or lymph node metastasis outside the surgical field.
- ≥18 years of age at the time of signing the Informed Consent Form. Renal function of eGFR \> 60 ml/min/1,73 m2.
- Physically fit for NAC.
- Clinical decision with patient accept of NAC before cystectomy.
- Mentally healthy. Signed Informed Consent Form.
Exclusion
- \- Unfit for MRI:
- Claustrophobia.
- Problems with seating arrangements (e.g. pain or involuntary movement).
- Maximal shoulder width larger than 55 cm.
- Circumference larger than 160 cm.
- Weight above 250 kg.
- Metallic implants or other metallic foreign bodies.
- Pacemaker, ICD, or pace electrodes.
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04321707
Start Date
May 27 2020
End Date
March 31 2023
Last Update
July 28 2021
Active Locations (1)
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1
Department of Urology, Aarhus University Hopsital
Aarhus, Denmark, 8000