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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2023-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D CT Scan

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

4D CT scan with respiratory gating

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.

Group Type EXPERIMENTAL

Respiratory gating

Intervention Type OTHER

10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality

Interventions

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Respiratory gating

10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality

Intervention Type OTHER

Other Intervention Names

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breathing motion monitoring

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No