Clinical trial NCT05846165: InveStigAting Bladder fiELd-cycLing imAging
Official title: InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Bladder tumours
Field-Cycling Imaging
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2023-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Identification of bladder tumours by Field-Cycling Imaging (FCI) scan
timeFrame: At baseline
Secondary outcomes:
measure: Differentiation of bladder tumours assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Aberdeen
name: Anne Kiltie, Prof
role: STUDY_CHAIR
References: