Status:
UNKNOWN
Multi-parametric MRI/Fluorine-18 Fluciclovine PET-CT in Glioblastoma
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Tumor, Brain
Eligibility:
All Genders
18-100 years
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- Patients with any of the following are not eligible for the study:
- Hypersensitivity to Fluorine-18 Fluciclovine
- Hypersensitivity to MRI contrast media
- Acute renal failure or moderate renal impairment (estimated glomerular filtration rate \< 30 mL/min)
- Claustrophobia precluding imaging
- Non-MRI compatible implantable device e.g. pacemaker
- Uncontrolled pain
- Urinary incontinence
- Female patients must not be pregnant and if of child bearing age using adequate contraception
- Breast feeding
- Serious psychiatric co-morbidity
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03409549
Start Date
June 1 2019
End Date
October 31 2020
Last Update
August 6 2019
Active Locations (1)
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1
Department of Nuclear Medicine, St James's University Hospitals
Leeds, United Kingdom, LS9 7TF