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

Primary Purpose

Breast Cancer, Radiation-Induced Vascular Disease, Left Anterior Descending Coronary Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Respiratory gating
Sponsored by
Central Hospital Saint Quentin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 yo Sex=female Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting. Be able to understand and give her personal free consent, no judicial protection measure. Written or oral consent, in compliance with the clinical investigation rules and regulation. Patient affiliated with social security system Treatment expected to be realized in Saint Quentin Hospital Exclusion Criteria: Patient < 18 yo Pregnant women. Breastfeeding women. Consent not given Claustrophobia Incapacited subject or judicial protection measure Other research with exclusion period time ongoing All the inclusion criteria not met

Sites / Locations

  • Saint Quentin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

3D CT Scan

4D CT scan with respiratory gating

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2023
Last Updated
June 8, 2023
Sponsor
Central Hospital Saint Quentin
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1. Study Identification

Unique Protocol Identification Number
NCT05726604
Brief Title
4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
Acronym
RD3D4
Official Title
4D CT Scan With Respiratory Gating Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital Saint Quentin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
breast cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D CT Scan
Arm Type
No Intervention
Arm 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.
Arm Title
4D CT scan with respiratory gating
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Respiratory gating
Other Intervention Name(s)
breathing motion monitoring
Intervention Description
10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality
Primary Outcome Measure Information:
Title
3D LAD mean dose vs 4D LAD mean dose
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 yo Sex=female Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting. Be able to understand and give her personal free consent, no judicial protection measure. Written or oral consent, in compliance with the clinical investigation rules and regulation. Patient affiliated with social security system Treatment expected to be realized in Saint Quentin Hospital Exclusion Criteria: Patient < 18 yo Pregnant women. Breastfeeding women. Consent not given Claustrophobia Incapacited subject or judicial protection measure Other research with exclusion period time ongoing All the inclusion criteria not met
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim Boulanouar
Phone
0323067861
Email
ak.boulanouar@ch-stquentin.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Farid BELKHIR, MD
Phone
0636967657
Email
vince07.me@gmail.com
Facility Information:
Facility Name
Saint Quentin Hospital
City
Saint-Quentin
State/Province
Hauts-de-france
ZIP/Postal Code
02100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farid BELKHIR, MD, PhD
Phone
0636967657
Email
kowalski.normandie@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Vincent Kowalski, MD
First Name & Middle Initial & Last Name & Degree
Farid BELKHIR, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.acc.org/latest-in-cardiology/articles/2018/05/24/01/44/radiation-induced-cad
Description
Radiation-Induced CAD: Incidence, Diagnosis, and Management Outcomes, American College of Cardiology 2018, Borges et al
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6775290/
Description
Radiation-induced heart disease: a review of classification, mechanism and prevention, Int J Biol Sci.2019 , Wang et al
URL
https://doi.org/10.1016/j.ijrobp.2018.06.091
Description
" Comparing whole heart versus coronary artery dosimetry in predicting the risk of cardiac toxicity following breast radiation therapy" Red Journal 102, Sa Patel et al
URL
https://pubmed.ncbi.nlm.nih.gov/23421926/
Description
Delineation of target volumes and organs at risk in adjuvant radiotherapy of early breast cancer: national guidelines and contouring atlas by the Danish Breast Cancer Cooperative Group" Acta Oncologica 2013, Nielsen et al
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5474560/
Description
Tangential Field Radiotherapy for Breast Cancer-The Dose to the Heart and Heart Subvolumes: What Structures Must Be Contoured in Future Clinical Trials? Front Oncol 2017, Duma et al.

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

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