4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy (RD3D4)

Central Hospital Saint Quentin

Status: Enrolling

Conditions: Radiotherapy Side Effect; Breast Cancer; Left Sided Breast Cancer; Cardiac Ischemia; Left Anterior Descending Coronary Artery Stenosis; Radiation-Induced Vascular Disease; LAD (Left Anterior Descending) Coronary Artery Stenosis

Treatments: Other: Respiratory gating

Study type: Interventional

Funder types: Other

Identifiers

NCT05726604

2022-A02337-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

3D CT Scan

No Intervention group

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.

4D CT scan with respiratory gating

Experimental group

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.

Treatment:

Other: Respiratory gating