4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy

NCT05726604 | Unknown

• 1 other identifier: 2022-A02337-36
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 3D LAD mean dose vs 4D LAD mean dose

  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). Based 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.

  1 week

Study Arms (2)

3D CT Scan

NO INTERVENTION

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.

4D CT scan with respiratory gating

EXPERIMENTAL

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.

Other: Respiratory gating

Interventions

Respiratory gating OTHER

10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality

Also known as: breathing motion monitoring

4D CT scan with respiratory gating

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 yo
• Sex=female
• Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting.
• Be able to understand and give her personal free consent, no judicial protection measure.
• Written or oral consent, in compliance with the clinical investigation rules and regulation.
• Patient affiliated with social security system
• Treatment expected to be realized in Saint Quentin Hospital

You may not qualify if:

• Patient \< 18 yo
• Pregnant women.
• Breastfeeding women.
• Consent not given
• Claustrophobia
• Incapacited subject or judicial protection measure

Sponsors & Collaborators

• Central Hospital Saint Quentin: lead

Study Sites (1)

Saint Quentin Hospital

Saint-Quentin, Hauts-de-France, 02100, France

RECRUITING

Related Links

• Radiation-Induced CAD: Incidence, Diagnosis, and Management Outcomes, American College of Cardiology 2018, Borges et al
• Risk of Ischemic Heart Disease in Women after Radiotherapy for Breast Cancer, N England J Med 2013, Darby et al
• Radiation-induced heart disease: a review of classification, mechanism and prevention, Int J Biol Sci.2019 , Wang et al
• " 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
• 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
• 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.

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries; Coronary Artery Disease; Unilateral Breast Neoplasms; Leukocyte adhesion deficiency type 1; Coronary Stenosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Karim Boulanouar

CONTACT

0323067861; ak.boulanouar@ch-stquentin.fr

Farid BELKHIR, MD

CONTACT

0636967657; vince07.me@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: March 2, 2023
• Primary Completion: June 5, 2023
• Study Completion: June 15, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

FR (1)