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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥18.
  • - WHO Performance status 0-2 (Appendix 1) - Histologically proven GBM (WHO Grade 4) - Clinical decision made to proceed with radical treatment with surgery and chemo-radiotherapy.
  • - Residual tumour following surgery as defined by the surgeons at the time of resection.
  • - Able to provide fully informed written consent.
  • - 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.

Exclusion Criteria:

Patients with any of the following are not eligible for the study: 1. Hypersensitivity to Fluorine-18 Fluciclovine. 2. Hypersensitivity to MRI contrast media. 3. Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min) 4. Claustrophobia precluding imaging. 5. Non-MRI compatible implantable device e.g. pacemaker. 6. Uncontrolled pain. 7. Urinary incontinence. 8. Female patients must not be pregnant and if of child bearing age using adequate contraception. 9. Breast feeding. 10. Serious psychiatric co-morbidity

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03409549
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Leeds Teaching Hospitals NHS Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tumor, Brain

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Leeds, United Kingdom

Status

Recruiting

Address

Department of Nuclear Medicine, St James's University Hospitals

Leeds, , LS9 7TF

Site Contact

Andrew Scarsbrook

[email protected]

01132068212