LymphomaDOLPHIN-VIVONCT04162431
DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (Ex Vivo Phase)
An observational study of Lymphoma and Head and Neck Cancer, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Head and Neck Cancer
- What is being tested?
- spectroscopic measurement, FNA biopsy and histopathology and cytology
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2021to 7 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients unable to consent to the study due to communication difficulties
- Patients unable to consent to the study due to lack of capacity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, GL1 3NN
About this study
Official title: Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (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.
Read more
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.
Read the 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.).
- Conditions
- Lymphoma, Head and Neck Cancer
- Being tested
- spectroscopic measurement, FNA biopsy, histopathology and cytology
- Keywords
- Raman, Lymphoma
- Medical subject headings
- Lymphoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectroscopic measurementDiagnostic test
Also called raman, infra red
measurement of the tissue with spectroscopy
FNA biopsyDiagnostic test
Also called fine needle aspiration biopsy
a fine needle aspiration (FNA) biopsy will be taken
histopathology and cytologyDiagnostic test
Histopathology and cytology will be performed on the samples
| Study group | Role | What they receive |
|---|---|---|
| non-hodgkin lymphoma | patients diagnosed with non-hodgkin lymphoma Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology | |
| hodgkin lymphoma | patients diagnosed with hodgkin lymphoma Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology | |
| squamous cell carcinoma | patients diagnosed with squamous cell carcinoma Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology | |
| reactive | patients diagnosed with a reactive (non-cancerous) lymph node Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology | |
| other | none of the above. Other cancer and non-cancer conditions Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Diagnostic discrimination
Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma \& malignant nodes from benign nodes
Measured: 3 years
Secondary outcomes (3)
Cancer Performance evaluation
Evaluation of the performance of a Raman needle probe to detect lymphoma \& malignancy in excised head \& neck lymph nodes and differentiate from benign nodes
Measured: 3 years
Understanding of Raman on lymph nodes
To develop our understanding of vibrational spectroscopy signal characteristics in head \& neck lymph nodes (through Raman \& FTIR mapping measurements of tissue sections).
Measured: 3 years
General Performance evaluation
Evaluation of the performance of a Raman needle probe to measure head \& neck lymph nodes (ergonomic design, ease of use etc.)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start28 Jun 2021
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Gloucestershire Hospitals NHS Foundation Trust, University of Bristol
- Responsible party
- Sponsor
- Investigators
- Nick Stone, Study director, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162431
- Sponsor's protocol ID
- 1819/31
- Other IDs
- 258155, II-LB-1117-20002
- Acronym
- DOLPHIN-VIVO
- Status last verified
- Jun 2024
- First submitted
- 11 Nov 2019
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unique study number and MRN (medical records number) (hospital number)
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (Ex Vivo Phase)
- ClinicalTrials.gov ID
- NCT04162431
- Acronym / sponsor ID
- DOLPHIN-VIVO / 1819/31
- Conditions
- Lymphoma, Head and Neck Cancer
- Keywords
- Raman, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Gloucestershire Hospitals NHS Foundation Trust, University of Bristol
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| non-hodgkin lymphoma | – | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with non-hodgkin lymphoma |
| hodgkin lymphoma | – | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with hodgkin lymphoma |
| squamous cell carcinoma | – | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with squamous cell carcinoma |
| reactive | – | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with a reactive (non-cancerous) lymph node |
| other | – | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologynone of the above. Other cancer and non-cancer conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients unable to consent to the study due to communication difficulties
- Patients unable to consent to the study due to lack of capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectroscopic measurementAlso: raman, infra redmeasurement of the tissue with spectroscopy | Diagnostic test | hodgkin lymphoma, non-hodgkin lymphoma, other, reactive, squamous cell carcinoma |
| FNA biopsyAlso: fine needle aspiration biopsya fine needle aspiration (FNA) biopsy will be taken | Diagnostic test | hodgkin lymphoma, non-hodgkin lymphoma, other, reactive, squamous cell carcinoma |
| histopathology and cytologyHistopathology and cytology will be performed on the samples | Diagnostic test | hodgkin lymphoma, non-hodgkin lymphoma, other, reactive, squamous cell carcinoma |
Primary outcome
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.
Diagnostic discrimination
Time frame: 3 years
Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma \& malignant nodes from benign nodes
3 secondary outcomes
Cancer Performance evaluation
Time frame: 3 years
Understanding of Raman on lymph nodes
Time frame: 3 years
General Performance evaluation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No. Unique study number and MRN (medical records number) (hospital number)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Stone study director
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Head and Neck Cancer, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe spectroscopic measurement (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.