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TerminatedNo phase

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

Key facts

Who runs it
University of Exeter
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
People taking part
14 people enrolled
Started
2 Sept 2024
Ended
17 Jun 2025
Type of study
Interventional, 5 groups
Treatments tested
  • spectroscopic measurement
  • FNA biopsy
  • histopathology and cytology
Record updated
26 June 2025
Why it stopped
Funding extension not granted

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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 take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 5 groups in the trial

  • non-hodgkin lymphomaTreatment being tested

    patients diagnosed with non-hodgkin lymphoma

    Treatment: spectroscopic measurement, FNA biopsy, and histopathology and cytology

  • hodgkin lymphomaTreatment being tested

    patients diagnosed with hodgkin lymphoma

    Treatment: spectroscopic measurement, FNA biopsy, and histopathology and cytology

  • squamous cell carcinomaTreatment being tested

    patients diagnosed with squamous cell carcinoma

    Treatment: spectroscopic measurement, FNA biopsy, and histopathology and cytology

  • reactiveTreatment being tested

    patients diagnosed with a reactive (non-cancerous) lymph node

    Treatment: spectroscopic measurement, FNA biopsy, and histopathology and cytology

  • otherTreatment being tested

    none of the above. Other cancer and non-cancer conditions

    Treatment: spectroscopic measurement, FNA biopsy, and histopathology and cytology

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (In Vivo Phase)
Record updated
26 June 2025