Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 12:56 PM
Study NCT ID:
NCT05726604
Status:
UNKNOWN
Last Update Posted:
2023-06-09
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000069584', 'term': 'Unilateral Breast Neoplasms'}, {'id': 'C535887', 'term': 'Leukocyte adhesion deficiency type 1'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3D LAD mean dose vs 4D LAD mean dose', 'timeFrame': '1 week', 'description': 'To determine if the mean LAD (left anterior descending artery) dose significantly changes statistically between an usual 3D CT scan versus a 4D CT with breathing motion monitoring (10 breathing phases are monitored).\n\nBased on stastical test with 95% confidence intervals, to evaluate if there is a significant difference between 4D CT LAD mean dose and 3D CT LAD mean dose.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer', 'Radiation-Induced Vascular Disease', 'Left Anterior Descending Coronary Artery Stenosis', 'Radiotherapy Side Effect', 'Cardiac Ischemia', 'Left Sided Breast Cancer', 'LAD (Left Anterior Descending) Coronary Artery Stenosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.acc.org/latest-in-cardiology/articles/2018/05/24/01/44/radiation-induced-cad', 'label': 'Radiation-Induced CAD: Incidence, Diagnosis, and Management Outcomes, American College of Cardiology 2018, Borges et al'}, {'url': 'https://doi.org/10.1056/NEJMoa1209825', 'label': 'Risk of Ischemic Heart Disease in Women after Radiotherapy for Breast Cancer, N England J Med 2013, Darby et al'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6775290/', 'label': 'Radiation-induced heart disease: a review of classification, mechanism and prevention, Int J Biol Sci.2019 , Wang et al'}, {'url': 'https://doi.org/10.1016/j.ijrobp.2018.06.091', 'label': '" Comparing whole heart versus coronary artery dosimetry in predicting the risk of cardiac toxicity following breast radiation therapy" Red Journal 102, Sa Patel et al'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/23421926/', 'label': 'Delineation of target volumes and organs at risk in adjuvant radiotherapy of early breast cancer: national guidelines and contouring atlas by the Danish Breast Cancer Cooperative Group" Acta Oncologica 2013, Nielsen et al'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5474560/', 'label': 'Tangential Field Radiotherapy for Breast Cancer-The Dose to the Heart and Heart Subvolumes: What Structures Must Be Contoured in Future Clinical Trials? Front Oncol 2017, Duma et al.'}]}, 'descriptionModule': {'briefSummary': 'To establish if the cardiac radiation dose assesment is well aproximated with routine 3D CT scan compared to 4D CT experimental scan with respiratory gating (breath motion monitoring). The study population relates to left side breast cancers female patients that require a radiation therapy treatment.', 'detailedDescription': 'As a standard of care, the postoperative breast cancers radiation therapy is generally based on a 3 dimensions CT scan that does not incorporate the breathing motion by definition.\n\nMeanwhile, the patients must commonly receive the treatment in free motion breathing condition.\n\nMore of that, the Cardiac dose, especially the LAD (left anterior descending artery) dose has been established as the main cause of radiation induced ischemic heart disease (RIHD) and should be consider in the first place.\n\nIn more concrete terms, the higher the LAD dose is, the greater the RIHD relates: arise the LAD dose by 1 Gy means a 7.4% higher risk to cause a RIHD during the next 5 years.\n\nThat being said, to determine if the cardiac dosimetry and the dose-volume histograms (specifically for the left side breast cancer treatments including or not the internal mammary artery) obtained from a 3D CT scan reflect well or not the reality (which is widely subject to the breathing motion).\n\nFinally, because it has been established that a 4D CT scan can monitor the breathing motion, it seems definitely interesting to compare it with the average 3D CT scan to address this concern.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 yo\n2. Sex=female\n3. Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting.\n4. Be able to understand and give her personal free consent, no judicial protection measure.\n5. Written or oral consent, in compliance with the clinical investigation rules and regulation.\n6. Patient affiliated with social security system\n7. Treatment expected to be realized in Saint Quentin Hospital\n\nExclusion Criteria:\n\n1. Patient \\< 18 yo\n2. Pregnant women.\n3. Breastfeeding women.\n4. Consent not given\n5. Claustrophobia\n6. Incapacited subject or judicial protection measure\n7. Other research with exclusion period time ongoing\n8. All the inclusion criteria not met'}, 'identificationModule': {'nctId': 'NCT05726604', 'acronym': 'RD3D4', 'briefTitle': '4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Central Hospital Saint Quentin'}, 'officialTitle': '4D CT Scan With Respiratory Gating Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy', 'orgStudyIdInfo': {'id': '2022-A02337-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '3D CT Scan', 'description': 'Assesment of an usual cardiac dosimetry based on 3D CT scan. Only this dosimetry will be used to treat the patients. Because of the crossover model, patients are included in both arms.'}, {'type': 'EXPERIMENTAL', 'label': '4D CT scan with respiratory gating', 'description': 'Assesment of an experimental cardiac dosimetry based on 4D CT scan. Not used to treat the patients. Because of the crossover model, patients are included in both arms.', 'interventionNames': ['Other: Respiratory gating']}], 'interventions': [{'name': 'Respiratory gating', 'type': 'OTHER', 'otherNames': ['breathing motion monitoring'], 'description': '10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality', 'armGroupLabels': ['4D CT scan with respiratory gating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02100', 'city': 'Saint-Quentin', 'state': 'Hauts-de-France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Farid BELKHIR, MD, PhD', 'role': 'CONTACT', 'email': 'kowalski.normandie@chu-amiens.fr', 'phone': '0636967657'}, {'name': 'Vincent Kowalski, MD', 'role': 'CONTACT'}, {'name': 'Farid BELKHIR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Quentin Hospital', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}], 'centralContacts': [{'name': 'Karim Boulanouar', 'role': 'CONTACT', 'email': 'ak.boulanouar@ch-stquentin.fr', 'phone': '0323067861'}, {'name': 'Farid BELKHIR, MD', 'role': 'CONTACT', 'email': 'vince07.me@gmail.com', 'phone': '0636967657'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital Saint Quentin', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}