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NCT Number: NCT06335667

mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer

This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).

Recruiting

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Key information

Conditions

Urothelial Bladder Cancer Muscle-invasive Bladder Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Nataliya Mar, MD

CONTACT

[email protected]

1-877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years old or greater at the time of consent.
  • Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.
  • ECOG Performance Status of 0-3.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).
  • Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.

Exclusion criteria

  • Prior TURBT within 120 days of study entry.
  • Prior therapy for bladder cancer within 180 days of study entry.
  • Inability to tolerate mpMRI or associated contrast.
  • Inability to tolerate TURBT or associated anesthesia.
  • ECOG Performance Status of 4.
  • Female patient who is known to be pregnant or breastfeeding.

Treatment and study plan

mpMRI + Diagnostic TURBT

Diagnostic Test

mpMRI in addition to the TURBT surgical procedure

Primary outcomes

  1. Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.

    Time frame: Up to 1 year

    VI-RADS is a five-point scoring system developed to standardize imaging and reporting of bladder tumor invasiveness on mpMRI. It predicts the degree of possible muscular propria invasion ("muscle-invasiveness") of bladder tumors. Once diagnostic TURBT is performed, the VI-RADS score from mpMRI will be compared to the pathologic tumor (T) stage from a diagnostic TURBT to assess for concordance.

Secondary outcomes

  1. Progression free survival (PFS) with mpMRI compared to diagnostic TURBT

    Time frame: up to 5 years

    Time from diagnostic test to cancer progression, recurrence, or death.

  2. Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy

    Time frame: up to 5 years

  3. Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).

    Time frame: up to 5 years

  4. Incidence of adverse events with mpMRI versus diagnostic TURBT.

    Time frame: up to 5 years

  5. Patient Quality of Life with mpMRI versus diagnostic TURBT.

    Time frame: up to 5 years

    As assessed by quality of life questionnaires

  6. Incidence of repeat TURBT.

    Time frame: up to 5 years

  7. Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT

    Time frame: up to 5 years

    in dollars

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Mar 28, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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