Clinical trial NCT04162431: DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (Ex Vivo Phase)
Official title: Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (Ex Vivo Phase)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Head and Neck Cancer
Keywords: Raman
Lymphoma
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Gloucestershire Hospitals NHS Foundation Trust
name: University of Bristol
First posted: 2019-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical head \& neck lymph node biopsy within Gloucestershire Hospitals NHS Foundation Trust Patients with a lump in their head or neck are sometimes referred by their GP for a biopsy. This often first involves taking a small sample of cells with a fine needle, guided by ultrasound, called a Fine Needle Aspiration (FNA) biopsy. If the result from this FNA biopsy is inconclusive, then they are often further referred for a surgical biopsy. Gloucestershire Hospitals NHS Foundation Trust is a tertiary referral centre for surgical head and neck biopsies.

Brief 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.

Detailed description: 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.).

Eligibility criteria: 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

Primary outcomes:
measure: Safe spectroscopic measurement
timeFrame: 3 years
measure: Diagnostic discrimination
timeFrame: 3 years
Secondary outcomes:
measure: Cancer Performance evaluation
timeFrame: 3 years
measure: Understanding of Raman on lymph nodes
timeFrame: 3 years
measure: General Performance evaluation
timeFrame: 3 years
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
state: Gloucestershire
Study officials:
affiliation: University of Exeter
name: Nick Stone
role: STUDY_DIRECTOR
References: