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

February 26, 2026 updated by: Jørgen Bjerggaard Jensen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 treatment. Methods for better selection of patients that potentially can avoid cystectomy is therefore needed.

15O-labeled water (H2O) is the gold standard for PET quantification of regional tissue perfusion. 15O-H2O has been validated as a freely diffusible tracer for measuring perfusion in the myocardium and cerebral blood flow and 15O-H2O PET is the golden standard for noninvasive imaging to quantify tumor blood flow (TBF).

Method: Patients scheduled for NAC followed by radical cystectomy due to histologically documented MIBC stage cT2-4a in the urinary bladder will be included. A 15O-H2O PET/MR scan will be performed at time of inclusion (baseline) and again after NAC prior to cystectomy.

Hypothesis: We hypothesize that changes in tumor architecture and perfusion estimated with 15O-H2O PET/MR measurements and clinical evaluation during NAC can identify patients with complete local response to chemotherapy and therefore select patients to avoid radical cystectomy.

Perspectives: This study will be the first to use 15O-H2O as tracer in bladder cancer. If proven efficient, evaluation of patients undergoing NAC with 15O-H2O PET/MR could potentially safely select patients for a true bladder sparring approach and potentially give some patients the choice of chemotherapy monotherapy, or in combination with other systemic oncological treatments like immunotherapy. If successful, this should be followed by randomized studies to document the clinical benefit and potentially reduce cost and increase quality of life by safely selecting patients for bladder sparring treatment of bladder cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jørgen Bjerggaard Jensen, Professor, consultant, MD
  • Phone Number: 004578452617
  • Email: bjergaard@skejby.rm.dk

Study Contact Backup

  • Name: Stefanie Korsgaard Körner, MD
  • Phone Number: 004530915431
  • Email: stkoer@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Urology, Aarhus University Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 15O-H2O PET/MR
All included patients will have two 15O-H2O PET/MR scan performed.
Radiation: 15O-H2O PET/MR
All included patients will have a 15O-H2O PET/MR scan performed at baseline and a scan performed after NAC, prior to cystectomy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in tumor blood flow
Time Frame: Comparison of scan made 1 week before NAC compared to scan 2 weeks after NAC
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jørgen Bjerggaard Jensen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAINTAIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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