An interventional study of Respiratory gating in Breast Cancer, Radiation-Induced Vascular Disease and Left Anterior Descending Coronary Artery Stenosis, sponsored by Central Hospital Saint Quentin. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by Central Hospital Saint Quentin · Not applicable, Interventional, and Other
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.
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.
16 studies on the registry are indexed under Unilateral Breast Neoplasms; 3 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 13 interventional studies indexed under Unilateral Breast Neoplasms.
Browse Unilateral Breast Neoplasms studies →Central Hospital Saint Quentin is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Compared within Unilateral Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
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
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
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.
Time frame: 1 week
Plan to share: Undecided
Ran from Mar 2023 to primary completion in Jun 2023, 3 months.
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Central Hospital Saint Quentin