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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

November 11, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed

1.6 years until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2024

Completed

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

November 11, 2019

Last Update Submit

June 10, 2024

Conditions

Lymphoma Head and Neck Cancer

Keywords

RamanLymphoma

Outcome Measures

Primary Outcomes (2)

Safe spectroscopic measurement
The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.
3 years
Diagnostic discrimination
Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma \& malignant nodes from benign nodes
3 years

Secondary Outcomes (3)

Cancer Performance evaluation
3 years
Understanding of Raman on lymph nodes
3 years
General Performance evaluation
3 years