Lymphoma
+1
DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (Ex Vivo Phase)
Sponsored by University of Exeter
About this trial
Last updated 3 years ago
Study ID
1819/31
Status
Recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All
Trial Timing
Ended 2 years ago
What is this trial about?
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.
The investigators 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
a low power laser is shone on to it. The investigators 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, the technique 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.
The investigators 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.
The investigators propose to measure spectra from excess lymph node biopsy samples taken
during standard routine diagnostic biopsy.
The investigators are also interested to see if they can successfully extract a fine needle
aspiration (FNA) biopsy sample using the device, as well as record a RS measurement. If
successful this would ease clinical adoption as the study could run in parallel with existing
standard routine clinical practice, using just one device.
This study will evaluate the 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.
What are the participation requirements?
Inclusion Criteria
- Patients undergoing biopsy or excision of lymph nodes as part of their routine clinical care within Gloucestershire Hospitals NHS Foundation Trust.
- Patients undergoing lymphadenectomy as part of routine treatment
Exclusion Criteria
- Patients unable to consent to the study due to communication difficulties
- Patients unable to consent to the study due to lack of capacity
Locations
Location
Status
Recruiting