InveStigAting Bladder fiELd-cycLing imAging

Bladder Cancer Clinical Trial

— ISABELLA  

Official title:

InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05846165
• Other study ID #: 2-115-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: March 2024

Study information

• Verified date: April 2023
• Source: University of Aberdeen
• Contact: Celia G Alvarez Campano, Dr
• Phone: +44 1224 437828
• Email: celia.alvarezcampano[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• Field-Cycling Imaging (FCI)
FCI scan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	NHS Grampian

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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