FCI-Glioblastoma Study

Applying New MRI Technology to Improve Outcomes From Chemoradiotherapy Treatment for Adult Patients With Glioblastoma

The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can tell the difference between tumour growth (progression) and 'pseudo-progression' (which looks like tumour but is not cancerous tissue) in patients with glioblastoma. The main question it aims to answer is:

• Can FCI differentiate glioblastoma progression from pseudo-progression?

Participants will undergo a standard MRI scan and an FCI scan, three times during the study. One before starting adjuvant chemotherapy, another one after three cycles and one at the end of treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioblastom WHO Grade 4
• Intervention / Treatment: Other: Baseline Field-Cycling Imaging research scan; Other: Baseline 3T MRI research scan; Other: Second Field-Cycling Imaging research scan; Other: Second 3T MRI research scan; Other: Final Field-Cycling Imaging research scan; Other: Final 3T MRI research scan

• Study Type: Observational
• Enrollment (Estimated): 18

Contacts and Locations

• Study Contact: Name: Anne Kiltie, Prof; Phone Number: +44 1224438651; Email: anne.kiltie@abdn.ac.uk
• Study Contact Backup: Name: Rafael Moleron, Dr; Email: rafael.moleron@nhs.scot

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom
    • University of Aberdeen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants treated at Aberdeen Royal Infirmary with histologically confirmed newly diagnosed glioblastoma who have completed radical chemoradiation with 60 Gy in 30 fractions over 6 weeks radiotherapy to the tumour and concurrent temozolomide chemotherapy, and who are due to start adjuvant temozolomide 4 weeks after completion of chemoradiation.

Description

Inclusion Criteria:

• Patients scheduled to have standard adjuvant temozolomide treatment for glioblastoma, within four weeks following radical radiotherapy with concomitant temozolomide
• 18 to 70 years old
• Life expectancy at least 12 weeks
• Able to undergo MRI scans lasting up to 1 hour each
• On stable or reducing dose of steroids for at least 5 days
• Able to provide informed consent
• Able to understand written and spoken English

Exclusion Criteria:

• Previous treatment for glioblastoma other than surgery and chemoradiation.
• Previous radiotherapy to brain and/or prior chemotherapy for lower grade glioma.
• Planned additional treatment with Tumor-Treating Fields
• Previous cytotoxic wafers or implants at the time of neurosurgery
• Uncontrolled intercurrent illness
• Being pregnant or nursing
• Conventional MRI contraindications
• Known allergy to contrast agent
• Unable to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Glioblastoma; Participants with histologically confirmed newly diagnosed glioblastoma who have completed radical chemoradiation and are due to start adjuvant chemotherapy 4 weeks after completion of chemoradiation.

Other: Baseline Field-Cycling Imaging research scan; FCI scan at baseline; Other: Baseline 3T MRI research scan; MRI scan at baseline; Other: Second Field-Cycling Imaging research scan; FCI scan after three cycles of chemotherapy; Other: Second 3T MRI research scan; MRI scan after three cycles of chemotherapy; Other: Final Field-Cycling Imaging research scan; FCI scan at the end of chemotherapy; Other: Final 3T MRI research scan; MRI scan at the end of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparisons of FCI with a) the MRI images at 6 months from start of chemotherapy (tumour/no tumour) and, b) clinical judgement of Consultant Clinical Oncologist and Consultant Neuroradiologist on presence of tumour (or not) at 6 months.	R1 maps will be generated from FCI data acquired at each field using a multi-field fitting approach. R1 values will be extracted from the co-registered 3T tissue maps and compared between tissue types and with 3T measures of tissue physiology such as perfusion, ADC, FA and T2*. The dispersion profiles will be fitted using a power law model to extract the scaling factor (A) and the exponent (β), with adaptations if required.	At six months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying unique imaging biomarkers of tissue structure that yield additional diagnostic information over existing non-invasive imaging methods, which could be tested in future clinical trials.	For identification of potential biomarkers, FCI images will be registered to the MRI images to obtain the T1 NMRD profiles of the pseudo-progressions. Dispersions models will be applied similarly to previous in vitro studies and comparison tests will be used to determine the best biomarker candidates that discriminate tumour residues from total clearance.	At six months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with long term tumour recurrence	Tumour recurrence identified in routine clinical MRI scans, for up to 5 years.	Up to five years after baseline.

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: NHS Grampian
• Investigators: Study Chair: Anne Kiltie, Prof, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Glioblastoma; Field-Cycling Imaging; FCI
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 2-080-25; TSC/24/35 (Other Grant/Funding Number: Chief Scientist Office (CSO) of the Scottish Government)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No