Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 11:55 PM
Study NCT ID:
NCT05010369
Status:
TERMINATED
Last Update Posted:
2025-06-26
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (In Vivo Phase)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073758', 'term': 'Nonlinear Optical Microscopy'}, {'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D003584', 'term': 'Cytological Techniques'}], 'ancestors': [{'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011677', 'term': 'Punctures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Funding extension not granted', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra', 'timeFrame': '3 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Safe in vivo measurement of lymph nodes using Raman spectroscopy to acquire diagnostic quality spectra', 'timeFrame': '3 years', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Raman', 'Lymphoma'], 'conditions': ['Lymphoma', 'Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nThe investigators propose to measure spectra from excess lymph node biopsy samples taken during standard routine diagnostic biopsy.\n\nThe 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.\n\nThis 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.', 'detailedDescription': 'Surplus lymph node tissue collected from patients undergoing routine surgical treatment for head \\& neck disease will be investigated using vibrational spectroscopy.\n\nThe 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.\n\nAims\n\nTo demonstrate that the FNA/Raman spectroscopy probe device, developed as part of this project, can:\n\nSafely 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.\n\nTo develop the investigators understanding of vibrational spectroscopy signal characteristics in head \\& neck lymph nodes (through Raman \\& FTIR mapping measurements of tissue sections).\n\nObjectives To test a new combined FNA and spectroscopic device on ex vivo tissue in preparation for an in vivo study.\n\nOutcome\n\nPrimary Outcome Measures The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.\n\nDiagnostic performance of vibrational spectroscopy for differentiation of lymphoma \\& malignant nodes from benign nodes.\n\nSecondary 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).\n\nEvaluation of the performance of a Raman needle probe to measure head \\& neck lymph nodes (ergonomic design, ease of use etc.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing biopsy or excision of more than one lymph node as part of their routine clinical care within Gloucestershire Hospitals NHS Foundation Trust.\n* Patients undergoing lymphadenectomy as part of routine treatment\n\nExclusion Criteria:\n\n* Patients requiring biopsy of only one lymph node\n* Patients unable to consent to the study due to communication difficulties\n* Patients unable to consent to the study due to lack of capacity'}, 'identificationModule': {'nctId': 'NCT05010369', 'acronym': 'DOLPHIN-VIVO', 'briefTitle': 'DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (In Vivo Phase)', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (In Vivo Phase)', 'orgStudyIdInfo': {'id': '1819/31-1'}, 'secondaryIdInfos': [{'id': '272392', 'type': 'REGISTRY', 'domain': 'IRAS'}, {'id': 'II-LB-1117-20002', 'type': 'OTHER_GRANT', 'domain': 'NIHR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-hodgkin lymphoma', 'description': 'patients diagnosed with non-hodgkin lymphoma', 'interventionNames': ['Diagnostic Test: spectroscopic measurement', 'Diagnostic Test: FNA biopsy', 'Diagnostic Test: histopathology and cytology']}, {'type': 'EXPERIMENTAL', 'label': 'hodgkin lymphoma', 'description': 'patients diagnosed with hodgkin lymphoma', 'interventionNames': ['Diagnostic Test: spectroscopic measurement', 'Diagnostic Test: FNA biopsy', 'Diagnostic Test: histopathology and cytology']}, {'type': 'EXPERIMENTAL', 'label': 'squamous cell carcinoma', 'description': 'patients diagnosed with squamous cell carcinoma', 'interventionNames': ['Diagnostic Test: spectroscopic measurement', 'Diagnostic Test: FNA biopsy', 'Diagnostic Test: histopathology and cytology']}, {'type': 'EXPERIMENTAL', 'label': 'reactive', 'description': 'patients diagnosed with a reactive (non-cancerous) lymph node', 'interventionNames': ['Diagnostic Test: spectroscopic measurement', 'Diagnostic Test: FNA biopsy', 'Diagnostic Test: histopathology and cytology']}, {'type': 'EXPERIMENTAL', 'label': 'other', 'description': 'none of the above. Other cancer and non-cancer conditions', 'interventionNames': ['Diagnostic Test: spectroscopic measurement', 'Diagnostic Test: FNA biopsy', 'Diagnostic Test: histopathology and cytology']}], 'interventions': [{'name': 'spectroscopic measurement', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['raman', 'infra red'], 'description': 'measurement of the tissue with spectroscopy', 'armGroupLabels': ['hodgkin lymphoma', 'non-hodgkin lymphoma', 'other', 'reactive', 'squamous cell carcinoma']}, {'name': 'FNA biopsy', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['fine needle aspiration biopsy'], 'description': 'a fine needle aspiration (FNA) biopsy will be taken', 'armGroupLabels': ['hodgkin lymphoma', 'non-hodgkin lymphoma', 'other', 'reactive', 'squamous cell carcinoma']}, {'name': 'histopathology and cytology', 'type': 'DIAGNOSTIC_TEST', 'description': 'Histopathology and cytology will be performed on the samples', 'armGroupLabels': ['hodgkin lymphoma', 'non-hodgkin lymphoma', 'other', 'reactive', 'squamous cell carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Gloucestershire Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}], 'overallOfficials': [{'name': 'Nick Stone', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Unique study number and MRN (medical records number) (hospital number)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gloucestershire Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University of Bristol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}