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

Breast Cancer Clinical Trial

— RD3D4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726604
• Other study ID #: 2022-A02337-36
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2023
• Source: Central Hospital Saint Quentin
• Contact: Karim Boulanouar
• Phone: 0323067861
• Email: ak.boulanouar[@]ch-stquentin.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Meanwhile, the patients must commonly receive the treatment in free motion breathing condition. More 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. In 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. That 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). Finally, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 15, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 yo

2. Sex=female

3. Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting.

4. Be able to understand and give her personal free consent, no judicial protection measure.

5. Written or oral consent, in compliance with the clinical investigation rules and regulation.

6. Patient affiliated with social security system

7. Treatment expected to be realized in Saint Quentin Hospital

Exclusion Criteria:

1. Patient < 18 yo

2. Pregnant women.

3. Breastfeeding women.

4. Consent not given

5. Claustrophobia

6. Incapacited subject or judicial protection measure

7. Other research with exclusion period time ongoing

8. All the inclusion criteria not met

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiac Ischemia
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Stenosis
• Ischemia
• Left Anterior Descending Coronary Artery Stenosis
• Left Sided Breast Cancer
• Myocardial Ischemia
• Radiotherapy Side Effect
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Saint Quentin Hospital	Saint-Quentin	Hauts-de-france

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital Saint Quentin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   " 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
•   Radiation-Induced CAD: Incidence, Diagnosis, and Management Outcomes, American College of Cardiology 2018, Borges et al
•   Radiation-induced heart disease: a review of classification, mechanism and prevention, Int J Biol Sci.2019 , Wang 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.