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

Rekrutierend

NCT-Nummer:
NCT04533672

Studienbeginn:
Februar 2021

Letztes Update:
01.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
Swiss National Science Foundation

Kontakt

Andreas Hötker, MD
Kontakt:
Phone: +41 44 255 29 20
E-Mail: andreas.hoetker@usz.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Zurich
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Andreas Hötker, MD
E-Mail: andreas.hoetker@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

1. Muscle-invasiveness (Time Frame - through study completion, an average of 4 years):
Presence of tumor infiltration into the muscular bladder wall, as per pathology report (infiltration: yes/no)

Geprüfte Regime

MRI Sequences:
New multiparametric MRI techniques

Quelle: ClinicalTrials.gov