FCI-Glioblastoma Study

NCT07443176 | Not Yet Recruiting

• 2 other identifiers: 2-080-25TSC/24/35
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastom WHO Grade 4

Keywords

Glioblastoma; Field-Cycling Imaging; FCI; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  At six months after baseline

Other Outcomes (1)

• Number of participants with long term tumour recurrence

  Up to five years after baseline.

Study Arms (1)

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; 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

Interventions

Baseline Field-Cycling Imaging research scan OTHER

FCI scan at baseline

Glioblastoma

Baseline 3T MRI research scan OTHER

MRI scan at baseline

Glioblastoma

Second Field-Cycling Imaging research scan OTHER

FCI scan after three cycles of chemotherapy

Glioblastoma

Second 3T MRI research scan OTHER

MRI scan after three cycles of chemotherapy

Glioblastoma

Final Field-Cycling Imaging research scan OTHER

FCI scan at the end of chemotherapy

Glioblastoma

Final 3T MRI research scan OTHER

MRI scan at the end of chemotherapy

Glioblastoma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients scheduled to have standard adjuvant temozolomide treatment for glioblastoma, within four weeks following radical radiotherapy with concomitant temozolomide
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Anne Kiltie, Prof

  University of Aberdeen

  STUDY CHAIR

Central Study Contacts

Anne Kiltie, Prof

CONTACT

+44 1224438651; anne.kiltie@abdn.ac.uk

Rafael Moleron, Dr

CONTACT

rafael.moleron@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)