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

NCT03409549 | Unknown

• 1 other identifier: RD17/101925
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Tumor, Brain

Outcome Measures

Primary Outcomes (1)

• Measurment od tumour volumes following scans

  The patients tumour volumes from conventional MR, advanced MR and PET/CT will be the primary outcome measure.

  6 months

Interventions

Fluciclovine PET/CT RADIATION

Fluorine-18 Fluciclovine PET/CT scan of the brain

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twelve adult patients with glioblastoma undergoing radical treatment will be recruited

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Department of Nuclear Medicine, St James's University Hospitals

Leeds, LS9 7TF, United Kingdom

RECRUITING

Related Publications (1)

• Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.

  PMID: 34081125 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Andrew Scarsbrook, BMedSci BMBS FRCR

CONTACT

01132068212; a.scarsbrook@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 24, 2018
• Study Start: June 1, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

GB (1)