Breast Cancer, Cardiac Ischemia, LAD (Left Anterior Descending) Coronary Artery Stenosis, Left Anterior Descending Coronary Artery Stenosis, Left Sided Breast Cancer, Radiation-Induced Vascular Disease, Radiotherapy Side Effect
Conditions
Keywords
breast cancer
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.
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.
Interventions
OTHERRespiratory gating
10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality
Sponsors
Central Hospital Saint Quentin
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D LAD mean dose vs 4D LAD mean dose | 1 week | 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. |
Countries
France
Contacts
Primary ContactKarim Boulanouar
Backup ContactFarid BELKHIR, MD
Outcome results
None listed