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Trial record 1 of 83 for:    MAINTAIN | Aarhus, Denmark
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Complete Local Response to Neoadjuvant Chemotherapy in Patients With Muscle Invasive Bladder Cancer Evaluated by 15O-H2O PET/MR (MAINTAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321707
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Radiation: 15O-H2O PET/MR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective, explorative, single arm, non-randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Complete Local Response to Neoadjuvant Chemotherapy in Patients With Muscle Invasive Bladder Cancer Evaluated by 15O-H2O PET/MR
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321707


Contacts
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Contact: Jørgen Bjerggaard Jensen, Professor, consultant, MD 004578452617 bjergaard@skejby.rm.dk
Contact: Stefanie Korsgaard Körner, MD 004530915431 stkoer@rm.dk

Locations
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Denmark
Department of Urology, Aarhus University Hopsital Recruiting
Aarhus, Denmark, 8000
Contact: Jørgen Bjerggaard Jensen, Professor, consultant, MD    004578452617    bjerggaard@skejby.rm.dk   
Contact: Stefanie Kosgaard Körner, MD    004530915431    stkoer@rm.dk   
Sponsors and Collaborators
Jørgen Bjerggaard Jensen
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Responsible Party: Jørgen Bjerggaard Jensen, Professor, Consultant, MD, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04321707    
Other Study ID Numbers: MAINTAIN
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jørgen Bjerggaard Jensen, Aarhus University Hospital:
Tumor blood flow
magnetic resonans imaging
15O water PET
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases