Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04323618
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in reproducibility of respiratory-related tumour motion (via fiducial maker surrogacy) for liver cancer patients treated with the AV biofeedback respiratory guidance system.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cancer patients, either primary hepatocellular carcinoma or liver metastases, eligible for stereotactic radiotherapy.\n* \\>18 years old\n* Radio-opaque markers implanted (fiducials and/or surgical clips previously implanted in the liver)\n* Able to give written informed consent and willingness to participate and comply with the study\n\nExclusion Criteria:\n\n* Pregnant / lactating women'}, 'identificationModule': {'nctId': 'NCT04323618', 'acronym': 'LAVA', 'briefTitle': 'Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing Stereotactic Body Radiotherapy Treatment (SBRT) Using Audiovisual (AV) Biofeedback', 'orgStudyIdInfo': {'id': 'LAVA V4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Free breathing or Breathe Well', 'description': 'Free breathing or Breathe Well', 'interventionNames': ['Device: Breathe Well']}], 'interventions': [{'name': 'Breathe Well', 'type': 'DEVICE', 'armGroupLabels': ['Free breathing or Breathe Well']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}