METRE v0.1

  • Research type

    Research Study

  • Full title

    Multi-paramEtric imaging to assess Treatment REsponse after stereotactic radiosurgery of brain metastases

  • IRAS ID

    275626

  • Contact name

    Liam Welsh

  • Contact email

    liam.welsh@rmh.nhs.uk

  • Sponsor organisation

    Royal Marsden NHS foundation trust

  • Clinicaltrials.gov Identifier

    NCT04626206

  • Duration of Study in the UK

    0 years, 8 months, 2 days

  • Research summary

    Routine follow-up for all patients after stereotactic radiosurgery (SRS) includes a standard brain magnetic resonance imaging (MRI) 3 months after completion of SRS. Sometimes this MRI is difficult to interpret and cannot reliably differentiate between tumour progression/recurrence (cancer getting bigger/returning) or expected radiotherapy-related changes associated with SRS (radionecrosis). This makes it challenging to make future management plans. The definitive way of differentiating progression/recurrence from radionecrosis is resection/biopsy (surgery) of the area in question and examination of the tissue but this is not always possible.

    The most comprehensive imaging technique we have to date, to help differentiate tumour progression/recurrence from radionecrosis is multi-parametric MRI but this is a resource intensive investigation and not viable in routine clinical practice. Therefore there is an urgent need for a viable imaging technique for this indication.

    It has been demonstrated that contrast-clearance analysis MRI can be used to help differentiate tumour versus radionecrosis. Contrast-clearance analysis MRI is FDA approved and CE marked but there is still sparse data on its efficacy. Though there is some evidence for the use of 18F-choline PET/CT in primary brain tumours, we need more evidence to validate its use in brain metastases.
    We aim to run a prospective pilot study recruiting 12 non-small-cell lung cancer patients with brain metastases whose follow-up brain MRI after SRS is unclear if changes seen are tumour progression/recurrence or radionecrosis. We consider multi-parametric MRI gold standard. Patients will undergo multi-parametric MRI, contrast-clearance analysis MRI and 18F-choline PET/CT. The 3 scans will be analysed by neuroradiologists and compared to determine if contrast-clearance analysis MRI and/or 18F-choline PET/CT are equivalent to multi-parametric MRI in discriminating tumour progression from radionecrosis.If so then that supports the continued use of these more readily available and viable forms of imaging to support clinical decision making in patients undergoing SRS.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    20/SC/0445

  • Date of REC Opinion

    29 Dec 2020

  • REC opinion

    Further Information Favourable Opinion