Breast CancerRD3D4NCT05726604
4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
A study testing Respiratory gating in people with Breast Cancer and Radiation-Induced Vascular Disease, run by Central Hospital Saint Quentin at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiation-Induced Vascular Disease, Left Anterior Descending Coronary Artery Stenosis
- What is being tested?
- Respiratory gating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint Quentin Hospital
Saint-Quentin, Hauts-de-France, 02100
Farid BELKHIR, MD, PhD, 0636967657, kowalski.normandie@chu-amiens.fr
Vincent Kowalski, MD
About this study
Official title: 4D CT Scan With Respiratory Gating Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
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.
Read the 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.
- Conditions
- Breast Cancer, Radiation-Induced Vascular Disease, Left Anterior Descending Coronary Artery Stenosis, Radiotherapy Side Effect, Cardiac Ischemia, Left Sided Breast Cancer
- Being tested
- Respiratory gating
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms, Radiation Injuries, Coronary Artery Disease, Unilateral Breast Neoplasms, Leukocyte adhesion deficiency type 1, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory gatingOther
Also called breathing motion monitoring
10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality
| Study group | Role | What they receive |
|---|---|---|
| 3D CT Scan | No intervention | 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. |
| 4D CT scan with respiratory gating | Experimental | 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. Receives: Other: Respiratory gating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start2 Mar 2023
- Primary completion5 Jun 2023
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital Saint Quentin
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726604
- Sponsor's protocol ID
- 2022-A02337-36
- Acronym
- RD3D4
- Status last verified
- Jun 2023
- First submitted
- 3 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D CT Scan With Respiratory Gating Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
- ClinicalTrials.gov ID
- NCT05726604
- Acronym / sponsor ID
- RD3D4 / 2022-A02337-36
- Conditions
- Breast Cancer, Radiation-Induced Vascular Disease, Left Anterior Descending Coronary Artery Stenosis, Radiotherapy Side Effect, Cardiac Ischemia, Left Sided Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Central Hospital Saint QuentinOther government
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D CT Scan | No intervention | –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. |
| 4D CT scan with respiratory gating | Experimental | Other: Respiratory gatingAssesment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Patient < 18 yo
- Pregnant women.
- Breastfeeding women.
- Consent not given
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory gatingAlso: breathing motion monitoring10 minutes breathing motion monitoring during an additional CT scan to establish a more accurate cardiac and LAD dosimetry compared to reality | Other | 4D CT scan with respiratory gating |
Primary outcome
3D LAD mean dose vs 4D LAD mean dose
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Radiation-induced heart disease: a review of classification, mechanism and prevention, Int J Biol Sci.2019 , Wang et alLink provided by the sponsor.
- " Comparing whole heart versus coronary artery dosimetry in predicting the risk of cardiac toxicity following breast radiation therapy" Red Journal 102, Sa Patel et alLink provided by the sponsor.
- 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 alLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory gating in people with Breast Cancer and Radiation-Induced Vascular Disease, run by Central Hospital Saint Quentin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim Boulanouar (0323067861, ak.boulanouar@ch-stquentin.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D LAD mean dose vs 4D LAD mean dose (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.