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

Not Applicable

Not yet recruiting

• Conditions: Lymphoma; Head and Neck Cancer
• Interventions: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology

• Registration Number: NCT05010369
• Lead Sponsor: University of Exeter

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.).

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Study Start: 2024-08
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients undergoing biopsy or excision of more than one lymph node as part of their routine clinical care within Gloucestershire Hospitals NHS Foundation Trust.
• Patients undergoing lymphadenectomy as part of routine treatment

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Exclusion Criteria

• Patients requiring biopsy of only one lymph node
• Patients unable to consent to the study due to communication difficulties
• Patients unable to consent to the study due to lack of capacity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hodgkin lymphoma	FNA biopsy	patients diagnosed with hodgkin lymphoma
non-hodgkin lymphoma	spectroscopic measurement	patients diagnosed with non-hodgkin lymphoma
hodgkin lymphoma	spectroscopic measurement	patients diagnosed with hodgkin lymphoma
squamous cell carcinoma	FNA biopsy	patients diagnosed with squamous cell carcinoma
reactive	histopathology and cytology	patients diagnosed with a reactive (non-cancerous) lymph node
non-hodgkin lymphoma	histopathology and cytology	patients diagnosed with non-hodgkin lymphoma
non-hodgkin lymphoma	FNA biopsy	patients diagnosed with non-hodgkin lymphoma
hodgkin lymphoma	histopathology and cytology	patients diagnosed with hodgkin lymphoma
squamous cell carcinoma	histopathology and cytology	patients diagnosed with squamous cell carcinoma
reactive	FNA biopsy	patients diagnosed with a reactive (non-cancerous) lymph node
other	spectroscopic measurement	none of the above. Other cancer and non-cancer conditions
squamous cell carcinoma	spectroscopic measurement	patients diagnosed with squamous cell carcinoma
reactive	spectroscopic measurement	patients diagnosed with a reactive (non-cancerous) lymph node
other	histopathology and cytology	none of the above. Other cancer and non-cancer conditions
other	FNA biopsy	none of the above. Other cancer and non-cancer conditions

Primary Outcome Measures

Name	Time	Method
Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra	3 years	Testing of the device for clinical application during surgery to demonstrate its use is safe and that is able to acquire diagnostic-quality spectra in less than 5 seconds from lymph nodes.

Secondary Outcome Measures

Name	Time	Method
Safe in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra	3 years	Computer model using multivariate analysis able to discriminate between diseased and non-diseased tissue. The target specificity and sensitivity are low due to small study group sizes.

Trial Locations

Locations (1)

Gloucestershire Hospitals NHS Foundation Trust; 🇬🇧 Gloucester, Gloucestershire, United Kingdom