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InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)

Primary Purpose

Bladder Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Field-Cycling Imaging (FCI)
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bladder Cancer focused on measuring Bladder Cancer, Bladder tumours, Field-Cycling Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients attending for flexible cystoscopy found to have a tumour of at least 3 cm in diameter (muscle-invasive or non-muscle invasive) Participants must be aged 18 and above Participants who meet the safety criteria for undergoing an MRI scan Participants who are able to fit inside the scanner Participants must be able to give fully informed consent Participants must be mobile enough to be positioned onto the FCI scanner couch Exclusion Criteria: Patients with total hip replacement MRI-incompatible conditions, as detected in the MRI safety screening sheet Participants under 18 years old Participants who are unable to communicate in English Participants who are unable to give fully informed consent Women who are pregnant Restrictions to mobility that would prevent the correct positioning in the scanner Participants who suffer from claustrophobia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bladder tumours

    Arm Description

    Participants with muscle-invasive and non-muscle invasive bladder tumours of at least 3 cm in diameter will undergo one FCI scan.

    Outcomes

    Primary Outcome Measures

    Identification of bladder tumours by Field-Cycling Imaging (FCI) scan
    Validation of FCI T1 dispersion profiles as a non-invasive technology able to detect bladder tumours.

    Secondary Outcome Measures

    Differentiation of bladder tumours assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles
    Validation of FCI T1 dispersion profiles as a clinical tool for distinguishing non-muscle invasive from muscle-invasive bladder tumours.

    Full Information

    First Posted
    March 29, 2023
    Last Updated
    April 26, 2023
    Sponsor
    University of Aberdeen
    Collaborators
    NHS Grampian
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05846165
    Brief Title
    InveStigAting Bladder fiELd-cycLing imAging
    Acronym
    ISABELLA
    Official Title
    InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aberdeen
    Collaborators
    NHS Grampian

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this pilot study is explore the parameters that can be obtained in bladder tumours by Field-Cycling Imaging (FCI) in patients with both muscle-invasive and non-muscle invasive tumours. The main question it aims to answer is if FCI can give more diagnostic information than conventional tests. Participants will have one FCI scan and the results will be correlated with the results of CT urogram or CT scan.
    Detailed Description
    Patients with organ-confined muscle invasive bladder cancer are treated either by removal of their bladder at cystectomy or by organ-preserving treatment, generally following neoadjuvant chemotherapy. In some cases, the neoadjuvant chemotherapy can shrink the tumour so that it is clinically undetectable but there may still be tumour cells present microscopically. This presents a difficulty during planning of radiotherapy treatments, which could then miss the tumour and lead to tumour recurrence. Field-Cycling Imaging (FCI) is an emerging imaging technology pioneered at the University of Aberdeen. FCI can image human tissues non-invasively over a wide range of magnetic field strengths, directly informing on multi-scale tissue structure from nanometres to micrometres. FCI has already shown significant potential for enhanced diagnosis in a range of diseases, and recent results show several potential biomarkers of cancer in breast, colon, and brain. FCI has not been used in bladder cancer before. In this proof-of-concept study, we will recruit patients with both muscle-invasive and non-muscle invasive tumours to explore the parameters that can be obtained in bladder tumours by FCI. Results of the FCI scans will be correlated with the results of CT urogram or CT scan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer
    Keywords
    Bladder Cancer, Bladder tumours, Field-Cycling Imaging

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bladder tumours
    Arm Type
    Experimental
    Arm Description
    Participants with muscle-invasive and non-muscle invasive bladder tumours of at least 3 cm in diameter will undergo one FCI scan.
    Intervention Type
    Device
    Intervention Name(s)
    Field-Cycling Imaging (FCI)
    Intervention Description
    FCI scan
    Primary Outcome Measure Information:
    Title
    Identification of bladder tumours by Field-Cycling Imaging (FCI) scan
    Description
    Validation of FCI T1 dispersion profiles as a non-invasive technology able to detect bladder tumours.
    Time Frame
    At baseline
    Secondary Outcome Measure Information:
    Title
    Differentiation of bladder tumours assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles
    Description
    Validation of FCI T1 dispersion profiles as a clinical tool for distinguishing non-muscle invasive from muscle-invasive bladder tumours.
    Time Frame
    At baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients attending for flexible cystoscopy found to have a tumour of at least 3 cm in diameter (muscle-invasive or non-muscle invasive) Participants must be aged 18 and above Participants who meet the safety criteria for undergoing an MRI scan Participants who are able to fit inside the scanner Participants must be able to give fully informed consent Participants must be mobile enough to be positioned onto the FCI scanner couch Exclusion Criteria: Patients with total hip replacement MRI-incompatible conditions, as detected in the MRI safety screening sheet Participants under 18 years old Participants who are unable to communicate in English Participants who are unable to give fully informed consent Women who are pregnant Restrictions to mobility that would prevent the correct positioning in the scanner Participants who suffer from claustrophobia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Celia G Alvarez Campano, Dr
    Phone
    +44 1224 437828
    Email
    celia.alvarezcampano@abdn.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Kiltie, Prof
    Organizational Affiliation
    University of Aberdeen
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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