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InveStigAting Bladder fiELd-cycLing imAging

InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05846165
Acronym
ISABELLA
Enrollment
0
Registered
2023-05-06
Start date
2023-05-31
Completion date
2024-03-31
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder Cancer, Bladder tumours, Field-Cycling Imaging

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.

Interventions

Sponsors

NHS Grampian
CollaboratorOTHER_GOV
University of Aberdeen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026