DOLPHIN-VIVO (ex vivo study)

  • Research type

    Research Study

  • Full title

    DOLPHIN-Vivo: Diagnosis of LymPHoma IN Vivo (ex vivo phase)

  • IRAS ID

    258155

  • Contact name

    Pam Baxter

  • Contact email

    p.r.baxter2@exeter.ac.uk

  • Sponsor organisation

    University of Exeter

  • Clinicaltrials.gov Identifier

    19/028/GHT, GHNHSFT R&D Ref Number

  • Duration of Study in the UK

    2 years, 1 months, 27 days

  • Research summary

    Lymphoma diagnosis often involves removal and biopsy of one or more lymph nodes. Many (around half) of these diagnostic procedures show that no cancer is present, hence unnecessary removal results in numerous side effects and complications. The procedure is also highly invasive.

    We have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when we shine a low power laser on to it. We intend to use this technique, known as "Raman Spectroscopy" (RS) to tell if tissue in the node is cancerous or healthy. By combining RS with a fine needle, we can target tissues below the skin with minimal invasion. Our needle will provide the clinician with instant diagnosis without the delay and cost of a laboratory analysis by pathologists.
    We have designed a probe that slides through a fine needle, guided by ultrasound, to the lymph node. The space between the two needles provides space for cell aspirate.

    We propose to measure spectra from excess lymph node biopsy samples taken during standard routine diagnostic biopsy.

    We are also interested to see if we can sucessfully extract a fine needle aspiration (FNA) biopsy sample using our device, as well as record a RS measurement. If successful this would ease clinical adoption as our study could run in parallel with existing standard routine clinical practice, using just one device.

    This study will evaluate our new device on half a lymph node that will be excised and snap-frozen during a routine surgical biopsy, to gather data for submission of approvals for an in-vivo study to follow.

  • REC name

    London - Hampstead Research Ethics Committee

  • REC reference

    19/LO/1916

  • Date of REC Opinion

    17 Dec 2019

  • REC opinion

    Favourable Opinion