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NCT Number: NCT04162431

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

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.

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Key information

Conditions

Lymphoma Head and Neck Cancer Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

About this study

Surplus lymph node tissue collected from patients undergoing routine surgical treatment for head & neck disease will be investigated using vibrational spectroscopy.

The project will develop a combined FNA/Raman spectroscopy needle probe. This study will evaluate this device on excised lymph node tissue to gather data for submission of approvals for an in-vivo study to follow. Raman & FTIR (fourier transform infrared) spectra will be correlated with routine histopathology results using multivariate analysis methods. Cytology samples taken using the device will be compared with histopathology results.

Aims

To demonstrate that the FNA/Raman spectroscopy probe device, developed as part of this project, can:

Safely perform measurement of Raman spectra on excised lymph node tissue Safely perform FNA (fine needle aspiration) biopsies on excised lymph node tissue To evaluate the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes.

To develop the investigators understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).

Objectives To test a new combined FNA and spectroscopic device on ex vivo tissue in preparation for an in vivo study.

Outcome

Primary Outcome Measures The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.

Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma & malignant nodes from benign nodes.

Secondary Outcome Measures Evaluation of the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes. To develop the investigators understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).

Evaluation of the performance of a Raman needle probe to measure head & neck lymph nodes (ergonomic design, ease of use etc.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spectroscopic measurement

Diagnostic Test

measurement of the tissue with spectroscopy

Other names: raman, infra red

FNA biopsy

Diagnostic Test

a fine needle aspiration (FNA) biopsy will be taken

Other names: fine needle aspiration biopsy

histopathology and cytology

Diagnostic Test

Histopathology and cytology will be performed on the samples

Primary outcomes

  1. Safe spectroscopic measurement

    Time frame: 3 years

    The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.

  2. Diagnostic discrimination

    Time frame: 3 years

    Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma & malignant nodes from benign nodes

Secondary outcomes

  1. Cancer Performance evaluation

    Time frame: 3 years

    Evaluation of the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes

  2. Understanding of Raman on lymph nodes

    Time frame: 3 years

    To develop our understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).

  3. General Performance evaluation

    Time frame: 3 years

    Evaluation of the performance of a Raman needle probe to measure head & neck lymph nodes (ergonomic design, ease of use etc.)

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust
  • University of Bristol

Registry information

Official study title

Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (Ex Vivo Phase)

Acronym: DOLPHIN-VIVO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2019
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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