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

NCT04162431 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-06-11

No results posted yet for this study

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.

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.

Conditions

Interventions

DIAGNOSTIC_TEST

spectroscopic measurement

measurement of the tissue with spectroscopy

DIAGNOSTIC_TEST

FNA biopsy

a fine needle aspiration (FNA) biopsy will be taken

DIAGNOSTIC_TEST

histopathology and cytology

Histopathology and cytology will be performed on the samples

Sponsors & Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust

    collaborator OTHER

  • University of Bristol

    collaborator OTHER

  • University of Exeter

    lead OTHER

Principal Investigators

  • Nick Stone · University of Exeter

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2024-06-07
Completion
2024-06-07

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162431 on ClinicalTrials.gov