DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (Ex Vivo Phase)

Brief summary (registry, in English)

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 you commit to

• Study type: Observational
• Participants enrolled: 50
• From 28 Jun 2021 to the primary completion date, 7 Jun 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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