CClinicalTrials.gg
WithdrawnNCT05846165ISABELLAUpdated Oct 8, 2024

InveStigAting Bladder fiELd-cycLing imAging

An interventional study of Field-Cycling Imaging (FCI) in Bladder Cancer, sponsored by University of Aberdeen. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by University of Aberdeen · Not applicable, Interventional, and Basic science

Why this study was withdrawn
No participants identified. Funding ended
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • Bladder Cancer
  • Bladder tumours
  • Field-Cycling Imaging
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 170 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceField-Cycling Imaging (FCI)

    FCI scan

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: At baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05846165
Lead sponsor
University of Aberdeen
Collaborators
NHS Grampian
Responsible party
Sponsor
First posted
May 6, 2023
Start date
May 2023 (estimated)
Primary completion
Mar 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Oct 8, 2024

Study contacts

Anne Kiltie, Prof
study chair · University of Aberdeen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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