LymphomaDOLPHIN-VIVONCT05010369
DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (In Vivo Phase)
A study testing spectroscopic measurement, FNA biopsy and histopathology and cytology in people with 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 older
- Conditions the study is for
- Lymphoma, Head and Neck Cancer
- What is being tested?
- spectroscopic measurement, FNA biopsy and histopathology and cytology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2024to 17 Jun 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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 (In 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 | Experimental | patients diagnosed with non-hodgkin lymphoma Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology |
| hodgkin lymphoma | Experimental | patients diagnosed with hodgkin lymphoma Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology |
| squamous cell carcinoma | Experimental | patients diagnosed with squamous cell carcinoma Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology |
| reactive | Experimental | patients diagnosed with a reactive (non-cancerous) lymph node Receives: Diagnostic Test: spectroscopic measurement; Diagnostic Test: FNA biopsy; Diagnostic Test: histopathology and cytology |
| other | Experimental | 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.
Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra
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.
Measured: 3 years
Secondary outcomes (1)
Safe in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra
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.
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 posted18 Aug 2021
- Study start2 Sep 2024
- Primary completion26 Feb 2025
- Study completion17 Jun 2025
Why it stopped: Funding extension not granted
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010369
- Sponsor's protocol ID
- 1819/31-1
- Other IDs
- 272392, II-LB-1117-20002
- Acronym
- DOLPHIN-VIVO
- Status last verified
- Jun 2025
- First submitted
- 20 May 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (In Vivo Phase)
- ClinicalTrials.gov ID
- NCT05010369
- Acronym / sponsor ID
- DOLPHIN-VIVO / 1819/31-1
- Conditions
- Lymphoma, Head and Neck Cancer
- Keywords
- Raman, Lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding extension not granted
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Gloucestershire Hospitals NHS Foundation Trust, University of Bristol
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 18 Aug 2021 (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
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| non-hodgkin lymphoma | Experimental | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with non-hodgkin lymphoma |
| hodgkin lymphoma | Experimental | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with hodgkin lymphoma |
| squamous cell carcinoma | Experimental | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with squamous cell carcinoma |
| reactive | Experimental | Diagnostic Test: spectroscopic measurement, Diagnostic Test: FNA biopsy, Diagnostic Test: histopathology and cytologypatients diagnosed with a reactive (non-cancerous) lymph node |
| other | Experimental | 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra
Time frame: 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.
1 secondary outcome
Safe in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Funding extension not granted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. Unique study number and MRN (medical records number) (hospital number)
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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 principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spectroscopic measurement, FNA biopsy and histopathology and cytology in people with 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 3 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: stopped early, as of the sponsor's last update on 26 Jun 2025. 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 was stopped early (reason given: Funding extension not granted). Results are not available in the source record.
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?
Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra (time frame: 3 years). 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 26 Jun 2025.