NCT04321707Completed
Complete Local Response to Neoadjuvant Chemotherapy in Patients With Muscle Invasive Bladder Cancer Evaluated by 15O-H2O PET/MR
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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 cystectomy are histopathological without remnant tumor in the cystectomy specimen (T0). However, there is currently no optimal method to evaluate whether the patient is true T0 or has remnant tumor in need for consolidating radical treatment. The study aim is to investigate if 15O-H2O PET/MR can predict complete local response to neoadjuvant chemotherapy in patients with MIBC and thereby identify potential candidates for organ preservation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 11 Mar 2020
- Start date
- 27 May 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Diseases
- Bladder cancer
- NCT number
- NCT04321707
What you commit to
- Study type: Interventional
- Participants enrolled: 13
- From 27 May 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Metallic implants or other metallic foreign bodies.
Other
- \- 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.
- Pacemaker, ICD, or pace electrodes.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Aarhus University Hopsital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.