FCI-Glioblastoma Study

ConditionGlioblastom WHO Grade 4

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-70

SponsorUniversity of Aberdeen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Glioblastoma6 interventions

Trial 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

Other outcomes

Number of participants with long term tumour recurrence

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

Time frame

Up to five years after baseline.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aberdeen

Lead sponsor

NHS Grampian

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: