Complete Local Response to Neoadjuvant Chemotherapy in Patients With Muscle Invasive Bladder Cancer Evaluated by 15O-H2O PET/MR

NCT04321707 | Completed

• 1 other identifier: MAINTAIN
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bladder Cancer

Keywords

Tumor blood flow; magnetic resonans imaging; 15O water PET

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

15O-H2O PET/MR

EXPERIMENTAL

All included patients will have two 15O-H2O PET/MR scan performed.

Radiation: 15O-H2O PET/MR

Interventions

15O-H2O PET/MR RADIATION

All included patients will have a 15O-H2O PET/MR scan performed at baseline and a scan performed after NAC, prior to cystectomy.

15O-H2O PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead

Study Sites (1)

Department of Urology, Aarhus University Hopsital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Consultant, MD, DMSc

Model Details: A prospective, explorative, single arm, non-randomized clinical trial

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 25, 2020
• Study Start: May 27, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 27, 2026

Record last verified: 2023-08

Locations

DK (1)