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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162431
Recruitment Status : Suspended (Covid19)
First Posted : November 14, 2019
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Gloucestershire Hospitals NHS Foundation Trust
University of Bristol
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Lymphoma Head and Neck Cancer Diagnostic Test: spectroscopic measurement Diagnostic Test: FNA biopsy Diagnostic Test: histopathology and cytology

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.).

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (Ex Vivo Phase)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lymphoma

Group/Cohort Intervention/treatment
non-hodgkin lymphoma
patients diagnosed with non-hodgkin lymphoma
Diagnostic Test: spectroscopic measurement
measurement of the tissue with spectroscopy
Other Names:
  • raman
  • infra red

Diagnostic Test: FNA biopsy
a fine needle aspiration (FNA) biopsy will be taken
Other Name: fine needle aspiration biopsy

Diagnostic Test: histopathology and cytology
Histopathology and cytology will be performed on the samples

hodgkin lymphoma
patients diagnosed with hodgkin lymphoma
Diagnostic Test: spectroscopic measurement
measurement of the tissue with spectroscopy
Other Names:
  • raman
  • infra red

Diagnostic Test: FNA biopsy
a fine needle aspiration (FNA) biopsy will be taken
Other Name: fine needle aspiration biopsy

Diagnostic Test: histopathology and cytology
Histopathology and cytology will be performed on the samples

squamous cell carcinoma
patients diagnosed with squamous cell carcinoma
Diagnostic Test: spectroscopic measurement
measurement of the tissue with spectroscopy
Other Names:
  • raman
  • infra red

Diagnostic Test: FNA biopsy
a fine needle aspiration (FNA) biopsy will be taken
Other Name: fine needle aspiration biopsy

Diagnostic Test: histopathology and cytology
Histopathology and cytology will be performed on the samples

reactive
patients diagnosed with a reactive (non-cancerous) lymph node
Diagnostic Test: spectroscopic measurement
measurement of the tissue with spectroscopy
Other Names:
  • raman
  • infra red

Diagnostic Test: FNA biopsy
a fine needle aspiration (FNA) biopsy will be taken
Other Name: fine needle aspiration biopsy

Diagnostic Test: histopathology and cytology
Histopathology and cytology will be performed on the samples

other
none of the above. Other cancer and non-cancer conditions
Diagnostic Test: spectroscopic measurement
measurement of the tissue with spectroscopy
Other Names:
  • raman
  • infra red

Diagnostic Test: FNA biopsy
a fine needle aspiration (FNA) biopsy will be taken
Other Name: fine needle aspiration biopsy

Diagnostic Test: histopathology and cytology
Histopathology and cytology will be performed on the samples




Primary Outcome Measures :
  1. 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.

  2. Diagnostic discrimination [ Time Frame: 3 years ]
    Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma & malignant nodes from benign nodes


Secondary Outcome Measures :
  1. Cancer Performance evaluation [ Time Frame: 3 years ]
    Evaluation of the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes

  2. Understanding of Raman on lymph nodes [ Time Frame: 3 years ]
    To develop our understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).

  3. General Performance evaluation [ Time Frame: 3 years ]
    Evaluation of the performance of a Raman needle probe to measure head & neck lymph nodes (ergonomic design, ease of use etc.)


Biospecimen Retention:   Samples With DNA
Bisected fresh frozen lymph nodes


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients unable to consent to the study due to communication difficulties
  • Patients unable to consent to the study due to lack of capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162431


Locations
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United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Sponsors and Collaborators
University of Exeter
Gloucestershire Hospitals NHS Foundation Trust
University of Bristol
Investigators
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Study Director: Nick Stone University of Exeter
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT04162431    
Other Study ID Numbers: 1819/31
258155 ( Registry Identifier: IRAS )
II-LB-1117-20002 ( Other Grant/Funding Number: NIHR )
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Unique study number and MRN (medical records number) (hospital number)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Exeter:
Raman
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases