Bladder CancerISABELLANCT05846165
InveStigAting Bladder fiELd-cycLing imAging
A study testing Field-Cycling Imaging (FCI) in people with Bladder Cancer, run by University of Aberdeen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Field-Cycling Imaging (FCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Field-Cycling Imaging (FCI)
- Keywords
- Bladder Cancer, Bladder tumours, Field-Cycling Imaging
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Field-Cycling Imaging (FCI)Device
FCI scan
| Study group | Role | What they receive |
|---|---|---|
| Bladder tumours | Experimental | Participants with muscle-invasive and non-muscle invasive bladder tumours of at least 3 cm in diameter will undergo one FCI scan. Receives: Device: Field-Cycling Imaging (FCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (1)
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startMay 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: No participants identified. Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Anne Kiltie, Prof, Study chair, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846165
- Sponsor's protocol ID
- 2-115-22
- Acronym
- ISABELLA
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)
- ClinicalTrials.gov ID
- NCT05846165
- Acronym / sponsor ID
- ISABELLA / 2-115-22
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Bladder tumours, Field-Cycling Imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants identified. Funding ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- May 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder tumours | Experimental | Device: Field-Cycling Imaging (FCI)Participants with muscle-invasive and non-muscle invasive bladder tumours of at least 3 cm in diameter will undergo one FCI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Field-Cycling Imaging (FCI)FCI scan | Device | Bladder tumours |
Primary outcome
Identification of bladder tumours by Field-Cycling Imaging (FCI) scan
Time frame: At baseline
Validation of FCI T1 dispersion profiles as a non-invasive technology able to detect bladder tumours.
1 secondary outcome
Differentiation of bladder tumours assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kiltie, Prof study chair
University of Aberdeen
Questions about this trial
What is this clinical trial studying?
A study testing Field-Cycling Imaging (FCI) in people with Bladder Cancer, run by University of Aberdeen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of bladder tumours by Field-Cycling Imaging (FCI) scan (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 3 Nov 2026.