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Completed

NCT Number: NCT01918592

PET/MRI and Biomarkers in Bladder Cancer

Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers.

In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • invasive or locally advanced bladder cancer based on cystoscopic evaluation
  • Age: 18 to 85 years old
  • Language spoken: Finnish or Swedish
  • 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

  • Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
  • Infections: Patient must not have an uncontrolled serious infection
  • Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  • Patient refusing radical cystectomy or chemotherapy
  • Intravesical Bacillus Calmette-Guerin instillations within 6 months

Treatment and study plan

MRI/acetate-PET imaging

Device

Other names: Philips Ingenuity PET/MR device, 11C-acetate as PET-tracer

Primary outcomes

  1. staging accuracy of PET/MRI in bladder cancer

    Time frame: 3 months

    Accuracy of PET/MRI to stage newly diagnosed bladder cancer. MRI/PET staging results is compared to pathology report of TUR-BT and cystectomy specimens.

Secondary outcomes

  1. Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy

    Time frame: 3 mo

    Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy prior to radical cystectomy. MRI/PET results is compared to pathology report of cystectomy specimen.

Other outcomes

  1. Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy.

    Time frame: 6 mo

    Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy

Acronym: ACEBIB

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2013
Registry last updated
Apr 18, 2018

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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