FCI-Glioblastoma Study

N/ANot Yet RecruitingNCT07443176

University of Aberdeen18 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Glioblastom WHO Grade 4

Interventions

Baseline Field-Cycling Imaging research scanOTHER

FCI scan at baseline

Baseline 3T MRI research scanOTHER

MRI scan at baseline

Second Field-Cycling Imaging research scanOTHER

FCI scan after three cycles of chemotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Aberdeen

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: At six months after baseline

Secondary Outcomes

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.

Time frame: At six months after baseline

Central Contacts

Anne Kiltie, Prof

CONTACT

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

Rafael Moleron, Dr

CONTACT

rafael.moleron@nhs.scot

Data from ClinicalTrials.gov

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