Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-01 @ 9:20 PM
Study NCT ID:
NCT05746156
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2023-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Results of the lymphatic map will be blinded to the radiation oncologist'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is it feasible to perform lymphatic mapping in locally advanced cervical cancer? Is there visualisation of (multiple) lymph nodes in both sides of the tumor?', 'timeFrame': '2 years', 'description': 'feasibiliy'}], 'secondaryOutcomes': [{'measure': 'Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?', 'timeFrame': '2 years', 'description': 'comparison to RT treatment plan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '37306763', 'type': 'DERIVED', 'citation': 'Adam JA, Poel E, van Eck-Smit BLF, Mom CH, Stalpers LJA, Stoker J, Bipat S. Lymphatic mapping for image-guided radiotherapy in patients with locally advanced uterine cervical cancer: a feasibility study. EJNMMI Res. 2023 Jun 12;13(1):58. doi: 10.1186/s13550-023-00989-0.'}]}, 'descriptionModule': {'briefSummary': 'Lymphatic mapping is a procedure in which all lymph nodes with drainage from the primary tumor, i.e. all nodes with potential (micro)metastases, can be imaged. These nodes are not necessarily suspicious on other imaging techniques.\n\nThe goal of this feasibility study is to\n\n1. investigate the feasibility of the lymphatic mapping procedure in locally advanced cervical cancer\n2. study the agreement of the lymphatic map with the radiotherapy treatment plan including previous imaging (MRI / CT / FDG-PET/CT)', 'detailedDescription': 'Study population:\n\nAged ≥18 years, with locally advanced cervical cancer, that will be planned for radiotherapy.\n\nIntervention (if applicable): Lymphatic mapping will be performed on all study patients during the standard investigation under anaesthesia, to ensure painless injection of the radiopharmaceutical. Patients will receive 6-8 depots of \\[99mTc\\]Tc-nanocolloid peritumoral. Planar and SPECT/CT gamma camera images will be made at the department of Radiology and Nuclear medicine 3 hours and 12-24 hours after administration of the radiopharmaceutical. All radioactive lymph nodes will be included in the lymphatic map.\n\nThe radiation oncologist will determine the radiation therapy treatment plan blinded to the data of the lymphatic mapping. The lymphatic map will be compared to the radiation treatment plan and previous imaging (MRI / CT / FDG-PET/CT).\n\nMain study parameters/endpoints:\n\n1. Is it feasible to perform lymphatic mapping in locally advanced cervical cancer? Is there visualisation of (multiple) lymph nodes in both sides of the tumor?\n2. Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically proven locally advanced cervical cancer \\[FIGO stage IIB-IVA\\]. \\>18 years old. Treatment with curative (chemo)radiation. Signed informed consent.\n\nExclusion Criteria:\n\nPregnancy. Administration of the radioactive tracer cannot be ensured properly due to obesity Patients with tumors in which no circumferential injection of \\[99mTc\\]Tc-nanocolloid is possible due to the size or position of the tumor.'}, 'identificationModule': {'nctId': 'NCT05746156', 'acronym': 'LaMA', 'briefTitle': 'Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Lymphatic Mapping for Image Guided Radiotherapy in Patients With Locally Advanced Cervical Cancer, a Feasibility Study', 'orgStudyIdInfo': {'id': 'NL9323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lymphatic map', 'description': 'Lymphatic mapping will be performed', 'interventionNames': ['Diagnostic Test: lymphatic mapping']}], 'interventions': [{'name': 'lymphatic mapping', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Peritumoral injection of \\[99mTc\\]Tc-nanocolloid in 6-8 evenly distributed depots on both sides of the tumor, during investigation under anaesthesia. Number of depots depending on the size and localisation of the tumor.\n2. Planair and SPECT/CT imaging van de abdomen/pelvis 3h and 12-24h after injection at the department of radiology and nucleair medicine.', 'armGroupLabels': ['lymphatic map']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1100DD', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Dr Shandra Bipat PhD', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}