MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Imaging in Staging of Primary Prostate Cancer

NCT03537391

High Risk Prostate Cancer

COMPLETED NA

Use of PET/MRI Tracer to Further Understanding of Prostate Cancer Development

NCT02106416

Prostate Cancer Bladder Cancer

COMPLETED NA

Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma With PET and MRI

NCT02002455

Prostate Carcinoma

COMPLETED PHASE2

Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers

NCT02141490

Prostate Cancer Bladder Cancer Kidney Cancer

COMPLETED PHASE2

Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

NCT02388126

Prostate Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MRI and biomarkers in bladder cancer

Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity

Group Type EXPERIMENTAL

MR imaging

Intervention Type DEVICE

3 T MRI of the urinary bladder

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MR imaging

3 T MRI of the urinary bladder

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 18 to 85 years old
* Suspected BC based on cystoscopical evaluation.
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria

* History of serious cardiovascular, liver or kidney disease
* Uncontrolled serious infection
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* Patient refusing radical cystectomy or chemotherapy or BCG
* Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No