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Multiparametric Magnetic Resonance Imaging (MRI) to Improve Bladder Cancer Staging and Treatment Decision-making (SBCT)

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MRI Sequences
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with confirmed or suspected primary bladder cancer and a circumscribed tumor/focal thickening of the bladder wall on initial imaging (ultrasound, CT) or cystoscopy with an approx. size of ≥ 1.5 cm/for which at least 2-3 TUR-B resection loops are necessary
  • Informed consent as documented by signature (Informed Consent Form)

Exclusion Criteria:

  • Prior TUR-B or other bladder treatment, prior treated bladder cancers, prior pelvic irradiation
  • Women who are pregnant or breast-feeding. Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).

Sites / Locations

  • University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single study arm

Arm Description

Outcomes

Primary Outcome Measures

Muscle-invasiveness
Presence of tumor infiltration into the muscular bladder wall, as per pathology report (infiltration: yes/no)

Secondary Outcome Measures

Full Information

First Posted
August 23, 2020
Last Updated
May 17, 2022
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04533672
Brief Title
Multiparametric Magnetic Resonance Imaging (MRI) to Improve Bladder Cancer Staging and Treatment Decision-making
Acronym
SBCT
Official Title
Multiparametric Magnetic Resonance Imaging (MRI) to Improve Bladder Cancer Staging and Treatment Decision-making
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The therapeutic approach to bladder cancer is strongly dependent on tumor stage and grade. Patients with non-muscle-invasive tumors (NMIBC) are usually treated with surgical resection of the tumor alone, whereas patients with muscle-invasive tumors (MIBC) ideally undergo neoadjuvant chemotherapy (NCT) and subsequent cystectomy. Magnetic Resonance Imaging (MRI) is emerging as a new staging modality, given its non-invasiveness and excellent soft tissue contrast. However, more advanced multiparametric MRI techniques are yet to be comprehensively investigated in patients with bladder cancer. Recently, genetic characteristics of bladder tumors have been identified that show significant impact on response rates to neoadjuvant treatment. The combination of new multiparametric MRI (mpMRI) techniques and genetic analyses of the tumor might allow for a better assessment of the expected clinical course of the disease and support more personalized treatment approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single study arm
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI Sequences
Intervention Description
New multiparametric MRI techniques
Primary Outcome Measure Information:
Title
Muscle-invasiveness
Description
Presence of tumor infiltration into the muscular bladder wall, as per pathology report (infiltration: yes/no)
Time Frame
through study completion, an average of 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with confirmed or suspected primary bladder cancer and a circumscribed tumor/focal thickening of the bladder wall on initial imaging (ultrasound, CT) or cystoscopy with an approx. size of ≥ 1.5 cm/for which at least 2-3 TUR-B resection loops are necessary Informed consent as documented by signature (Informed Consent Form) Exclusion Criteria: Prior TUR-B or other bladder treatment, prior treated bladder cancers, prior pelvic irradiation Women who are pregnant or breast-feeding. Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Previous enrolment into the current study Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Hötker, MD
Phone
+41 44 255 29 20
Email
andreas.hoetker@usz.ch
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Hötker, MD
Email
andreas.hoetker@usz.ch
First Name & Middle Initial & Last Name & Degree
Andreas Hötker, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multiparametric Magnetic Resonance Imaging (MRI) to Improve Bladder Cancer Staging and Treatment Decision-making

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