Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT05055206
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072098', 'term': 'Single Photon Emission Computed Tomography Computed Tomography'}], 'ancestors': [{'id': 'D015899', 'term': 'Tomography, Emission-Computed, Single-Photon'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients injected with radiotracer.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients requiring general anesthetic over local anesthetic.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients with images that failed radiotracer migration to either side of the neck.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients completing 30 minute scan.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients completing 3 hour scan.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients with radiotracer uptake into a radiographically positive lymph node.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.', 'timeFrame': '1 year'}, {'measure': 'Average time from start to finish of injection of procedure.', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients with complications associated with injection.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphatic Drainage Mapping', '99m-Technetium Sulfur Colloid'], 'conditions': ['Oropharynx Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer.', 'detailedDescription': 'This study will evaluate a technique called lymphatic drainage mapping. This is a technique where a radiotracer (a radioactive material that can be seen with a special computed tomography \\[CT\\] scanner to create 3D images) is injected into a vein around the tumour, either with local anesthesia or under general anesthesia. The radiotracer that will be used for the lymphatic drainage mapping is called 99m-Technetium Sulfur Colloid. Images will be taken of neck to detect the movement of the radiotracer. This will allow the doctors to see the drainage pattern of the lymph nodes in the neck.\n\nThe information from this study will be used to better understand the tendency for oropharyngeal cancers to spread to lymph nodes. In addition, the information from this clinical trial will be used in future clinical studies to help specialists identify strategies to help plan treatment based on this type of imaging study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline\n* Has squamous cell carcinoma, T1-3 tumours, with no contralateral nodes on clinical exam or axial imaging\n* Human papillomavirus (HPV) positive or negative\n* Patient should have normal organ function as per Investigator judgement\n* Patient is planned for definitive or adjuvant radiotherapy (RT) or chemo radiotherapy (CRT) with bilateral neck RT, or surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\nExclusion Criteria:\n\n* T4 tumours\n* Contralateral/bilateral nodal disease or node(s) \\> 6cm on clinical exam or axial imaging or positron emission tomography (PET)\n* Primary tumour involving or crossing midline\n* Soft palate or posterior pharyngeal wall tumour subsites\n* Previous head and neck cancer\n* Previous radiotherapy (RT) to the head and neck\n* Previous neck dissection\n* Distant metastases\n* Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for 3 years\n* Prior radiotracer allergy\n* Multiple primary head and neck cancers\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05055206', 'briefTitle': 'Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid', 'orgStudyIdInfo': {'id': 'SPECT-CT'}, 'secondaryIdInfos': [{'id': '20-5607', 'type': 'OTHER', 'domain': 'UHN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lymphatic drainage mapping in patients with oropharynx cancer', 'description': 'Participants will be given 4 to 6 injections of the radiotracer 99m-Technetium Sulfur Colloid by a needle into one of the veins of the radiotracer around the tumour.\n\nParticipants will then have at least 1 or possibly 2 SPECT-CT scans (a special x-ray scan of the body from many angles that are turned into 3-dimensional pictures on a screen).', 'interventionNames': ['Diagnostic Test: SPECT-CT']}], 'interventions': [{'name': 'SPECT-CT', 'type': 'DIAGNOSTIC_TEST', 'description': '99m-Technetium Sulfur Colloid will be injected prior to the scan.', 'armGroupLabels': ['Lymphatic drainage mapping in patients with oropharynx cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'John de Almeida, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}