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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05726604
Other study ID # 2022-A02337-36
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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