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Status unknownNCT03409549Updated Aug 6, 2019

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

An observational study in Tumor, Brain, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tumor, Brain
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Twelve adult patients with glioblastoma undergoing radical treatment will be recruited

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (estimated)
Patient registry
No

Interventions

  • RadiationFluciclovine PET/CT

    Fluorine-18 Fluciclovine PET/CT scan of the brain

05

What researchers measure

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.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Department of Nuclear Medicine, St James's University Hospitals
    Leeds, LS9 7TF, United Kingdom
    • Andrew Scarsbrook · Contact
    Recruiting
07

References and documents

Publications

  • 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. PubMed 34081125 ↗
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Registry details

Key details

Study ID
NCT03409549
Lead sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jun 1, 2019
Primary completion
Oct 31, 2020 (estimated)
Completion
Oct 31, 2020 (estimated)
Last update
Aug 6, 2019

Study contacts

Andrew Scarsbrook, BMedSci BMBS FRCR
Contact
a.scarsbrook@nhs.net
01132068212

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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