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

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

NCT ID: NCT05726604

Condition: 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

Conditions: Official terms:
Breast Neoplasms
Unilateral Breast Neoplasms
Vascular Diseases
Coronary Stenosis
Coronary Artery Disease
Myocardial Ischemia
Constriction, Pathologic

Conditions: Keywords:
breast cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Respiratory gating
Description: 10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality
Arm group label: 4D CT scan with respiratory gating

Other name: breathing motion monitoring

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Saint Quentin Hospital

Address:
City: Saint-Quentin
Zip: 02100
Country: France

Status: Recruiting

Contact:
Last name: Farid BELKHIR, MD, PhD

Phone: 0636967657
Email: kowalski.normandie@chu-amiens.fr

Contact backup:
Last name: Vincent Kowalski, MD

Investigator:
Last name: Farid BELKHIR, MD
Email: Principal Investigator

Start date: March 2, 2023

Completion date: June 15, 2023

Lead sponsor:
Agency: Central Hospital Saint Quentin
Agency class: Other

Source: Central Hospital Saint Quentin

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05726604
https://www.acc.org/latest-in-cardiology/articles/2018/05/24/01/44/radiation-induced-cad
https://doi.org/10.1056/NEJMoa1209825
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6775290/
https://doi.org/10.1016/j.ijrobp.2018.06.091
https://pubmed.ncbi.nlm.nih.gov/23421926/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5474560/