Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-02 @ 7:37 AM
Study NCT ID:
NCT07134192
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescence-Guided Optimization of Sarcoma Margins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'National multicenter interventional cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reresection', 'timeFrame': '30 days', 'description': 'Reresection within 30 days will be used as primary endpoint as a proxy for histopathologically positive margin status following surgery which would require reoperation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcoma', 'ICG', 'Indocyanine green', 'Fluorescence Guided Surgery', 'FGS', 'STS', 'Soft Tissue Sarcoma'], 'conditions': ['Soft Tissue Sarcoma of the Trunk and Extremities', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.', 'detailedDescription': 'This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.\n\nBiopsy verified intermediate-to-high grade sarcoma of the extremity or trunk wall are eligible for inclusion. To be included there must be curative intent at time of surgery.\n\nThe primary endpoint will be re-resection within 30 days due to positive margins on the initial resection. Tumor characteristics and margin status from pathology reports will be recorded. Data on reoperations due to other factors, positive margins without planned reoperation, or death will also be collected. Participants will undergo surgery with ICG administered and guided using the SPY-PHI.\n\nThe prospective cohort will be compared to a historic cohort having received standard of care treatment. The historic cohort is included to act as a control group to compare with the new procedure. The data is derived from the Danish Sarcoma Database and permissions for this is in process. This data does not involve access to patient EMRs.\n\nPatients will receive an intravenous bolus of 1 mg/kg fluorescent ICG dye 16-24 hours before surgery. During surgery, consecutive measurements will be recorded using the SPY-PHI. Surgical resection will be guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients.\n\nApproximately 20 minutes of additional surgical time is expected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall\n* Age\\>18 years old\n* Tumor operable\n* Curative intent at time of surgery\n* Consent of patient\n\nExclusion Criteria:\n\n* History of allergic reaction to iodine-containing pharmaceuticals\n* End-stage renal disease or eGFR \\<15\n* Patient decision\n* Lack of capacity\n* Inoperability'}, 'identificationModule': {'nctId': 'NCT07134192', 'acronym': 'FOCUS', 'briefTitle': 'Fluorescence-Guided Optimization of Sarcoma Margins', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Fluorescence-Guided Optimization of Sarcoma Margins', 'orgStudyIdInfo': {'id': '113942'}, 'secondaryIdInfos': [{'id': '1-10-72-34-25', 'type': 'OTHER', 'domain': 'Scientific Ethics Committees for the Central Denmark Region'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluorescence-guided surgery cohort', 'description': 'Patients with intermediate-to-high grade sarcomas eligible for curative surgical treatment at time of surgery. Surgery will be augmented by guidance through the use of a near-infrared camera and fluorescent dye administered the day prior to surgery.', 'interventionNames': ['Procedure: Fluorescent-guided Surgery']}], 'interventions': [{'name': 'Fluorescent-guided Surgery', 'type': 'PROCEDURE', 'description': 'Surgical treatment of the patient group will include the administration of a fluorescent dye and intraoperatively the resection will be aided and guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients', 'armGroupLabels': ['Fluorescence-guided surgery cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian Kveller, MD', 'role': 'CONTACT', 'email': 'chrkve@rm.dk', 'phone': '+45 51 48 13 19'}, {'name': 'Thomas Baad-Hansen, MD, PhD', 'role': 'CONTACT', 'email': 'thombaad@rm.dk', 'phone': '+45 28603490'}, {'name': 'Christian Kveller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2100', 'city': 'Copenhagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michael M Petersen, MD, PhD', 'role': 'CONTACT', 'email': 'Michael.Moerk.Petersen@regionh.dk', 'phone': '+45 3545 8900'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Christian Kveller, MD', 'role': 'CONTACT', 'email': 'chrkve@rm.dk', 'phone': '+45 51 48 13 19'}, {'name': 'Thomas Baad-Hansen, MD, PhD', 'role': 'CONTACT', 'email': 'thombaad@rm.dk', 'phone': '+45 28603490'}], 'overallOfficials': [{'name': 'Thomas Baad-Hansen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orthopedic Surgical Department, Aarhus University Hospital'}, {'name': 'Christian Kveller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Surgical Department, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}