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
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