InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)

InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Field-Cycling Imaging (FCI)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bladder tumours; Participants with muscle-invasive and non-muscle invasive bladder tumours of at least 3 cm in diameter will undergo one FCI scan.	Device: Field-Cycling Imaging (FCI); FCI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: NHS Grampian
• Investigators: Study Chair: Anne Kiltie, Prof, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Bladder Cancer; Bladder tumours; Field-Cycling Imaging
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2-115-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No