Bladder Cancer Clinical Trial
— MAINTAINOfficial title:
Complete Local Response to Neoadjuvant Chemotherapy in Patients With Muscle Invasive Bladder Cancer Evaluated by 15O-H2O PET/MR
NCT number | NCT04321707 |
Other study ID # | MAINTAIN |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 27, 2020 |
Est. completion date | March 31, 2023 |
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 | Recruiting |
Enrollment | 54 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Urology, Aarhus University Hopsital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Jørgen Bjerggaard Jensen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tumor blood flow | Change in Tumor Blood Flow (TBF) measured on 15O-H2O PET/MR as a marker of response to NAC correlated with histopathological findings in the cystectomy specimen. | Comparison of scan made 1 week before NAC compared to scan 2 weeks after NAC |
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