Glioblastom WHO Grade 4NCT07443176
FCI-Glioblastoma Study
An observational study of Glioblastom WHO Grade 4, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastom WHO Grade 4
- What is being tested?
- Baseline Field-Cycling Imaging research scan, Baseline 3T MRI research scan and Second Field-Cycling Imaging research scan
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Conventional MRI contraindications
- Known allergy to contrast agent
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rafael Moleron, Dr contact
About this study
Official title: 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.
- Conditions
- Glioblastom WHO Grade 4
- Being tested
- Baseline Field-Cycling Imaging research scan, Baseline 3T MRI research scan, Second Field-Cycling Imaging research scan, Second 3T MRI research scan, Final Field-Cycling Imaging research scan
- Keywords
- Glioblastoma, Field-Cycling Imaging, FCI, MRI
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Second 3T MRI research scanOther
MRI scan after three cycles of chemotherapy
Final Field-Cycling Imaging research scanOther
FCI scan at the end of chemotherapy
Final 3T MRI research scanOther
MRI scan at the end of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: At six months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastom WHO Grade 4Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Anne Kiltie, Prof, Study chair, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443176
- Sponsor's protocol ID
- 2-080-25
- Other IDs
- TSC/24/35
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying New MRI Technology to Improve Outcomes From Chemoradiotherapy Treatment for Adult Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT07443176
- Acronym / sponsor ID
- 2-080-25
- Conditions
- Glioblastom WHO Grade 4
- Keywords
- Glioblastoma, Field-Cycling Imaging, FCI, MRI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma | – | 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 scanParticipants with histologically confirmed newly diagnosed glioblastoma who have completed radical chemoradiation and are due to start adjuvant chemotherapy 4 weeks after completion of chemoradiation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Field-Cycling Imaging research scanFCI scan at baseline | Other | Glioblastoma |
| Baseline 3T MRI research scanMRI scan at baseline | Other | Glioblastoma |
| Second Field-Cycling Imaging research scanFCI scan after three cycles of chemotherapy | Other | Glioblastoma |
| Second 3T MRI research scanMRI scan after three cycles of chemotherapy | Other | Glioblastoma |
| Final Field-Cycling Imaging research scanFCI scan at the end of chemotherapy | Other | Glioblastoma |
| Final 3T MRI research scanMRI scan at the end of chemotherapy | Other | Glioblastoma |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Moleron, Dr contact
Anne Kiltie, Prof study chair
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastom WHO Grade 4, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Kiltie, Prof (+44 1224438651, anne.kiltie@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.