Clinical Trial · NCT03409549

Multi-parametric MRI/Fluorine-18 Fluciclovine PET-CT in Glioblastoma

Overview

Glioblastoma is the most common adult brain tumour with approximately 2000 new cases each year in the UK. Optimal treatment consists of surgery followed by radiotherapy and chemotherapy but despite this survival is poor with only 10% of patients alive at 5 years. Standard imaging (MRI and CT) may not detect the full extent of tumours before treatment and it can be difficult to assess how the tumour is responding to treatment. The study aims to evaluate more advanced imaging techniques to see if they are better at mapping the whole tumour and assessing response to treatment. Two different imaging techniques will be assessed: Positron Emission Tomography - Computed Tomography (PET-CT) uses a mildly radioactive compound injected into the patient which is taken up into brain tumour cells and shows up as a bright spot on scans. Brain tumours affect blood supply and how much fluid is in the brain tissue as well as how freely fluid can move around. Advanced MR imaging known as multiparametric MRI will be used to look at these additional features. This extra information may help improve planning of radiotherapy and assessing how tumours respond to treatment. Twelve adult patients with glioblastoma undergoing radical treatment will be recruited over a 12 month period. Each patient will have standard MR imaging before radiotherapy (after surgery) and 4-6 weeks following completion of radiotherapy. They will also have advanced MRI and PET/CT before, during and after treatment. The aim will be to study if this is feasible and could potentially improve radiotherapy planning and response assessment. Imaging will be interpreted by both imaging and brain tumour treatment experts.

Sponsor

Unknown Organization

Contacts

Andrew Scarsbrook, BMedSci BMBS FRCR (CONTACT)

a.scarsbrook@nhs.net

01132068212

ClinicalTrials.gov

NCT03409549

Drug / Compound

Fluciclovine

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Residual tumour following surgery as defined by the surgeons at the time of resection
  • Clinical decision made to proceed with radical treatment with surgery and chemo-radiotherapy
  • Histologically proven GBM (WHO Grade 4)
  • Able to lie flat for 1 hour
  • Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be post-menopausal.
  • WHO Performance status 0-2 (Appendix 1)
  • Able to provide fully informed written consent

Exclusion

  • Claustrophobia precluding imaging
  • Urinary incontinence
  • Breast feeding
  • Serious psychiatric co-morbidity
  • Uncontrolled pain
  • Acute renal failure or moderate renal impairment (estimated glomerular filtration rate \< 30 mL/min)
  • Hypersensitivity to MRI contrast media
  • Patients with any of the following are not eligible for the study:
  • Hypersensitivity to Fluorine-18 Fluciclovine
  • Non-MRI compatible implantable device e.g. pacemaker