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NCT Number: NCT07443176

FCI-Glioblastoma Study

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.

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Key information

Conditions

Glioblastom WHO Grade 4 Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Aberdeen

Aberdeen, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline Field-Cycling Imaging research scan

Other

FCI scan at baseline

Baseline 3T MRI research scan

Other

MRI scan at baseline

Second Field-Cycling Imaging research scan

Other

FCI scan after three cycles of chemotherapy

Second 3T MRI research scan

Other

MRI scan after three cycles of chemotherapy

Final Field-Cycling Imaging research scan

Other

FCI scan at the end of chemotherapy

Final 3T MRI research scan

Other

MRI scan at the end of chemotherapy

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.

    Time frame: At six months after baseline

    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.

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.

    Time frame: At six months after baseline

    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.

Other outcomes

  1. Number of participants with long term tumour recurrence

    Time frame: Up to five years after baseline.

    Tumour recurrence identified in routine clinical MRI scans, for up to 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Kiltie, Prof

CONTACT

[email protected]

+44 1224438651

Rafael Moleron, Dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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