NCT01918592

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

August 5, 2013

Last Update Submit

April 16, 2018

Conditions

Bladder Cancer

Keywords

bladder cancerneoadjuvant chemotherapyradical cystectomylymphadenectomybiomarker

Outcome Measures

Primary Outcomes (1)

  • staging accuracy of PET/MRI in bladder cancer

    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.

    3 months

Secondary Outcomes (1)

  • Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy

    3 mo

Other Outcomes (1)

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

    6 mo

Study Arms (1)

MRI/PET

EXPERIMENTAL
Device: MRI/acetate-PET imaging

Interventions

MRI/acetate-PET imagingDEVICE
Also known as: Philips Ingenuity PET/MR device, 11C-acetate as PET-tracer
MRI/PET

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helsinki University Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, 20100, Finland

Location

Related Publications (1)

  • Salminen A, Jambor I, Merisaari H, Ettala O, Virtanen J, Koskinen I, Veskimae E, Sairanen J, Taimen P, Kemppainen J, Minn H, Bostrom PJ. 11C-acetate PET/MRI in bladder cancer staging and treatment response evaluation to neoadjuvant chemotherapy: a prospective multicenter study (ACEBIB trial). Cancer Imaging. 2018 Aug 2;18(1):25. doi: 10.1186/s40644-018-0158-4.

    PMID: 30068379DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief, department of urology

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 8, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

FI(3)