Breast CancerEDIPENCT05454553
Efficacity of Deep Inspiration Breath Hold and Intensity-modulated Radiotherapy in Preventing PErfusion Defect for Left Sided Breast Cancer (EDIPE)
A study testing myocardial perfusion SPECT in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
Breast irradiation is known to cause radiation-induced heart disease (RIHD) many years later after radiotherapy. Recent studies suggest that RIHD could be an earlier complication and that subclinical cardiac injury can be detected such as myocardial perfusion defects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- myocardial perfusion SPECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2022to 27 Oct 2024
- 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
- Patient with left sided breast cancer histologically confirmed after lumpectomy or mastectomy with/without lymph node involvement who are planned for DIBH-RT or IMRT
- Age > 18 years
- Karnofsky Performance Status (KPS) > 60%
- Absence of psychiatric illness hindering follow-up
- Patient understands French
- Signature of informed consent
- Patient registered with social security
Who cannot join
- Bilateral breast cancer
- History of thoracic irradiation
- Pregnancy or breastfeeding
- Any medical contraindication of cardiac SPECT or chest CT angiography.
- Any medical contraindication of Regadenoson
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg
Manon VOEGELIN, promotion-rc@icans.eu
Martin SCHMITT, MD
About this study
Breast irradiation is known to cause radiation-induced heart disease (RIHD) many years later after radiotherapy. Recent studies suggest that RIHD could be an earlier complication and that subclinical cardiac injury can be detected such as myocardial perfusion defects. Myocardial perfusion single photon emission computed tomography (SPECT) is a sensitive and specific technique able to detect perfusion abnormalities which are more frequent in left-sided breast cancer patients because of the cardiac exposure.
The most used technique for breast cancer irradiation is tangential opposed field, but this technique exposes the left anterior descending coronary artery to high dose during left breast irradiation.
Read more
There are different cardiac sparing techniques to reduce heart exposure such as:
- Deep inspiration breath-hold (DIBH) which displaces the heart out of the radiation beam
- Intensity-modulated radiation therapy (IMRT) which decreases heart exposure to high doses but changes the dose distribution in the heart and increases lower doses.
Read the detailed description
In breast radiotherapy, especially for left sides breast cancers, the heart is the organ-at-risk which whose dose constraints are source of controversies. Historically breast cancer radiation therapy was associated with a significantly increased cardiac mortality. Two meta-analyses founded that the cardiac mortality risk was increased by 27% to 38%. This result is linked to outdated 2-D treatment techniques causing massive cardiac overexposure (Clarke M et al. 2005, Cheng YJ et al. 2017).
Three dimensional conformational radiotherapy reduced mean heart dose but the link between heart irradiation and radiation-induced heart damages doesn't seem to have threshold therefore to RHID is still a matter of concern (Darby SC et al. 2013; Taylor C et al. 2017).
The most used technique for breast cancer irradiation is opposite tangential field radiotherapy, however, it exposes the anterior interventricular coronary artery to a high dose during left breast irradiation (Nieder C et al. 2007). Therefore, radiotherapy techniques have developed to reduce cardiac exposure such as deep inspiration breath hold (DBIH) and intensity modulated radiation therapy (IMRT).
DBIH "mechanically" moves the heart away from the radiation beam and IMRT the dose distribution in the heart and reduces its exposure to high doses (Boda-Heggemann J et al. 2016, Lauche O et al. 2016).
Nevertheless, recent studies suggest that even with this level of cardiac exposure subclinical cardiac alterations may be detected, such as myocardial perfusion deficit (Eber et al. 2022; Marks LB et al. 2005; Gyenes G et al. 1997; Sioka C et al. 2011; Seddon B et al. 2002; Eftekhari M et al. 2015).
The heart is a complex and heterogeneous organ, however it's mostly considered as an homogeneous organ-at-risk during treatment planning in daily practice. Dosimetric optimization is therefore mainly performed on the global cardiac structure and the mean cardiac dose (MHD). Dosimetric studies reported a poor correlation between MHD and mean doses to cardiac substructures questioning the relevance of the MHD as a reflection of the dose distribution to the heart (Jacob S et al. 2016).
Recent data suggested to take account of the histological diversity and the functional complexity of the cardiac substructure (Darby SC et al. 2010; Gillette EL et al. 1985; Ghita M et al. 2020; Eber J et al. 2021). This delineation is not performed in routine clinical practice due to the poorly reproducible and time-consuming manual contouring.
The development of auto-segmentation software can save time and improve the quality of the delineation process of these substructures in order to optimize dosimetry (Feng M et al. 2011; Maffei N et al. 2020).
The investigators propose a single-centre prospective study to evaluate the utility of deep inspiration breath hold using a surface monitoring technique (AlignRT, Vision RT Ltd., London, UK) and IMRT, as means to prevent the development of myocardial perfusional deficits in patients treated for left breast cancer, using stress and, if necessary, resting myocardial scintigraphy.
Before initiation of radiotherapy patients will performed a chest CT scan in the treatment position for 3D treatment planning and dose calculation; a chest CT angiography for delineation of cardiac substructures; and a myocardial perfusion SPECT imaging to provide a map of regional myocardial perfusion and determine left ventricle ejection fraction (LVEF).
Treatment phase will consist of the standard course of breast radiotherapy in our department. The main difference will be in the delineation of the organ at risk, cardiac substructures will be delineated to obtain the dosimetry During the follow up period, patient will be scheduled to undergo cardiac SPECT before and at 3-, 6-, and 12-month period post irradiation. Stress ECG-gated SPECT will be performed after infusion of 3 MBq/kg 99mTc-tetrofosmin (Myoview®, General Electrics Healthcare) at peak pharmacological stress with regadenoson, (single dosage: 400 µg; Rapiscan®, GE healthcare)
- Conditions
- Breast Cancer
- Being tested
- myocardial perfusion SPECT
- Keywords
- Breast Cancer, Cardiac Toxicity, Deep Inspiration Breath Hold, Myocardial Perfusion Imaging
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial perfusion SPECTOther
For all participants, myocardial perfusion SPECT will be performed :
at 3, 6 and 12 months (post irradiation)
| Study group | Role | What they receive |
|---|---|---|
| Patients with left sided breast cancer who are planned for | Experimental | one of the following heart sparing techniques :
* DIBH radiotherapy
* IMRT Receives: Other: myocardial perfusion SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
Measured: at 3 months from the end of radiotherapy
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
Measured: at 6 months from the end of radiotherapy
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
Measured: at 12 months from the end of radiotherapy
Secondary outcomes (8)
Assession of wall-motion abnormalities and left ventricular ejection fraction (LVEF) decrease
Incidence of left ventricular wall motion disorder and LVEF quantification on follow-up myocardial perfusion SPECT scans.
Measured: up to 12 months from the end of radiotherapy
Assessing the relevance of mean heart dose in the prevention of Radiation-induced heart disease (RIHD) compared to cardiac substructures.
Measurement of the doses delivered to the cardiac volumes and its substructures.
Measured: up to 12 months from the end of radiotherapy
Influence of cardiac risk factors on post-radiation myocardial perfusion.
Measured: up to 12 months from the end of radiotherapy
Influence of anticancer therapy exposure on post-radiation myocardial perfusion
Anticancer therapy characteristics (type)
Measured: up to 12 months from the end of radiotherapy
Influence of anticancer therapy exposure on post-radiation myocardial perfusion
Anticancer therapy characteristics (dose)
Measured: up to 12 months from the end of radiotherapy
Influence of anticancer therapy exposure on post-radiation myocardial perfusion
Anticancer therapy characteristics (duration)
Measured: up to 12 months from the end of radiotherapy
Impact of the location of the tumor bed boost on the cardiac dose.
Location of the tumor bed boost
Measured: up to 12 months from the end of radiotherapy
Impact of the location of the tumor bed boost on the cardiac dose.
Cardiac dose
Measured: up to 12 months from the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start27 Oct 2022
- Primary completion27 Oct 2024 (estimated)
- Study completion27 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454553
- Sponsor's protocol ID
- 2021-012
- Other IDs
- ID-RCB
- Acronym
- EDIPE
- Status last verified
- Nov 2022
- First submitted
- 22 Jun 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
PubMed 16360786Cheng YJ, Nie XY, Ji CC, Lin XX, Liu LJ, Chen XM, Yao H, Wu SH. Long-Term Cardiovascular Risk After Radiotherapy in Women With Breast Cancer. J Am Heart Assoc. 2017 May 21;6(5):e005633. doi: 10.1161/JAHA.117.005633.
PubMed 28529208Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.
PubMed 23484825Taylor C, Correa C, Duane FK, Aznar MC, Anderson SJ, Bergh J, Dodwell D, Ewertz M, Gray R, Jagsi R, Pierce L, Pritchard KI, Swain S, Wang Z, Wang Y, Whelan T, Peto R, McGale P; Early Breast Cancer Trialists' Collaborative Group. Estimating the Risks of Breast Cancer Radiotherapy: Evidence From Modern Radiation Doses to the Lungs and Heart and From Previous Randomized Trials. J Clin Oncol. 2017 May 20;35(15):1641-1649. doi: 10.1200/JCO.2016.72.0722. Epub 2017 Mar 20.
PubMed 28319436Nieder C, Schill S, Kneschaurek P, Molls M. Influence of different treatment techniques on radiation dose to the LAD coronary artery. Radiat Oncol. 2007 Jun 5;2:20. doi: 10.1186/1748-717X-2-20.
PubMed 17547777Boda-Heggemann J, Knopf AC, Simeonova-Chergou A, Wertz H, Stieler F, Jahnke A, Jahnke L, Fleckenstein J, Vogel L, Arns A, Blessing M, Wenz F, Lohr F. Deep Inspiration Breath Hold-Based Radiation Therapy: A Clinical Review. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):478-92. doi: 10.1016/j.ijrobp.2015.11.049. Epub 2015 Dec 17.
PubMed 26867877Lauche O, Kirova YM, Fenoglietto P, Costa E, Lemanski C, Bourgier C, Riou O, Tiberi D, Campana F, Fourquet A, Azria D. Helical tomotherapy and volumetric modulated arc therapy: New therapeutic arms in the breast cancer radiotherapy. World J Radiol. 2016 Aug 28;8(8):735-42. doi: 10.4329/wjr.v8.i8.735.
PubMed 27648167Eber J, Leroy-Freschini B, Antoni D, Noel G, Pflumio C. Increased cardiac uptake of (18F)-fluorodeoxyglucose incidentally detected on positron emission tomography after left breast irradiation: How to interpret? Cancer Radiother. 2022 Sep;26(5):724-729. doi: 10.1016/j.canrad.2021.10.010. Epub 2022 Feb 12.
PubMed 35165015Marks LB, Yu X, Prosnitz RG, Zhou SM, Hardenbergh PH, Blazing M, Hollis D, Lind P, Tisch A, Wong TZ, Borges-Neto S. The incidence and functional consequences of RT-associated cardiac perfusion defects. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):214-23. doi: 10.1016/j.ijrobp.2005.01.029.
PubMed 16111592Gyenes G, Fornander T, Carlens P, Glas U, Rutqvist LE. Detection of radiation-induced myocardial damage by technetium-99m sestamibi scintigraphy. Eur J Nucl Med. 1997 Mar;24(3):286-92. doi: 10.1007/BF01728765.
PubMed 9143466Sioka C, Exarchopoulos T, Tasiou I, Tzima E, Fotou N, Capizzello A, Ragos V, Tsekeris P, Fotopoulos A. Myocardial perfusion imaging with (99 m)Tc-tetrofosmin SPECT in breast cancer patients that received postoperative radiotherapy: a case-control study. Radiat Oncol. 2011 Nov 8;6:151. doi: 10.1186/1748-717X-6-151.
PubMed 22067743Seddon B, Cook A, Gothard L, Salmon E, Latus K, Underwood SR, Yarnold J. Detection of defects in myocardial perfusion imaging in patients with early breast cancer treated with radiotherapy. Radiother Oncol. 2002 Jul;64(1):53-63. doi: 10.1016/s0167-8140(02)00133-0.
PubMed 12208576Eftekhari M, Anbiaei R, Zamani H, Fallahi B, Beiki D, Ameri A, Emami-Ardekani A, Fard-Esfahani A, Gholamrezanezhad A, Seid Ratki KR, Roknabadi AM. Radiation-induced myocardial perfusion abnormalities in breast cancer patients following external beam radiation therapy. Asia Ocean J Nucl Med Biol. 2015 Winter;3(1):3-9.
PubMed 27408875Jacob S, Pathak A, Franck D, Latorzeff I, Jimenez G, Fondard O, Lapeyre M, Colombier D, Bruguiere E, Lairez O, Fontenel B, Milliat F, Tamarat R, Broggio D, Derreumaux S, Ducassou M, Ferrieres J, Laurier D, Benderitter M, Bernier MO. Early detection and prediction of cardiotoxicity after radiation therapy for breast cancer: the BACCARAT prospective cohort study. Radiat Oncol. 2016 Apr 7;11:54. doi: 10.1186/s13014-016-0627-5.
PubMed 27056179Darby SC, Cutter DJ, Boerma M, Constine LS, Fajardo LF, Kodama K, Mabuchi K, Marks LB, Mettler FA, Pierce LJ, Trott KR, Yeh ET, Shore RE. Radiation-related heart disease: current knowledge and future prospects. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):656-65. doi: 10.1016/j.ijrobp.2009.09.064.
PubMed 20159360
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacity of Deep Inspiration Breath Hold and Intensity-modulated Radiotherapy in Preventing PErfusion Defect for Left Sided Breast Cancer (EDIPE)
- ClinicalTrials.gov ID
- NCT05454553
- Acronym / sponsor ID
- EDIPE / 2021-012
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cardiac Toxicity, Deep Inspiration Breath Hold, Myocardial Perfusion Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 27 Oct 2024 (estimated)
- Study completion
- 27 Oct 2024 (estimated)
- First posted
- 12 Jul 2022 (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.
Breast irradiation is known to cause radiation-induced heart disease (RIHD) many years later after radiotherapy. Recent studies suggest that RIHD could be an earlier complication and that subclinical cardiac injury can be detected such as myocardial perfusion defects. Myocardial perfusion single photon emission computed tomography (SPECT) is a sensitive and specific technique able to detect perfusion abnormalities which are more frequent in left-sided breast cancer patients because of the cardiac exposure.
The most used technique for breast cancer irradiation is tangential opposed field, but this technique exposes the left anterior descending coronary artery to high dose during left breast irradiation.
There are different cardiac sparing techniques to reduce heart exposure such as:
- Deep inspiration breath-hold (DIBH) which displaces the heart out of the radiation beam
- Intensity-modulated radiation therapy (IMRT) which decreases heart exposure to high doses but changes the dose distribution in the heart and increases lower doses.
Detailed description
In breast radiotherapy, especially for left sides breast cancers, the heart is the organ-at-risk which whose dose constraints are source of controversies. Historically breast cancer radiation therapy was associated with a significantly increased cardiac mortality. Two meta-analyses founded that the cardiac mortality risk was increased by 27% to 38%. This result is linked to outdated 2-D treatment techniques causing massive cardiac overexposure (Clarke M et al. 2005, Cheng YJ et al. 2017).
Three dimensional conformational radiotherapy reduced mean heart dose but the link between heart irradiation and radiation-induced heart damages doesn't seem to have threshold therefore to RHID is still a matter of concern (Darby SC et al. 2013; Taylor C et al. 2017).
The most used technique for breast cancer irradiation is opposite tangential field radiotherapy, however, it exposes the anterior interventricular coronary artery to a high dose during left breast irradiation (Nieder C et al. 2007). Therefore, radiotherapy techniques have developed to reduce cardiac exposure such as deep inspiration breath hold (DBIH) and intensity modulated radiation therapy (IMRT).
DBIH "mechanically" moves the heart away from the radiation beam and IMRT the dose distribution in the heart and reduces its exposure to high doses (Boda-Heggemann J et al. 2016, Lauche O et al. 2016).
Nevertheless, recent studies suggest that even with this level of cardiac exposure subclinical cardiac alterations may be detected, such as myocardial perfusion deficit (Eber et al. 2022; Marks LB et al. 2005; Gyenes G et al. 1997; Sioka C et al. 2011; Seddon B et al. 2002; Eftekhari M et al. 2015).
The heart is a complex and heterogeneous organ, however it's mostly considered as an homogeneous organ-at-risk during treatment planning in daily practice. Dosimetric optimization is therefore mainly performed on the global cardiac structure and the mean cardiac dose (MHD). Dosimetric studies reported a poor correlation between MHD and mean doses to cardiac substructures questioning the relevance of the MHD as a reflection of the dose distribution to the heart (Jacob S et al. 2016).
Recent data suggested to take account of the histological diversity and the functional complexity of the cardiac substructure (Darby SC et al. 2010; Gillette EL et al. 1985; Ghita M et al. 2020; Eber J et al. 2021). This delineation is not performed in routine clinical practice due to the poorly reproducible and time-consuming manual contouring.
The development of auto-segmentation software can save time and improve the quality of the delineation process of these substructures in order to optimize dosimetry (Feng M et al. 2011; Maffei N et al. 2020).
The investigators propose a single-centre prospective study to evaluate the utility of deep inspiration breath hold using a surface monitoring technique (AlignRT, Vision RT Ltd., London, UK) and IMRT, as means to prevent the development of myocardial perfusional deficits in patients treated for left breast cancer, using stress and, if necessary, resting myocardial scintigraphy.
Before initiation of radiotherapy patients will performed a chest CT scan in the treatment position for 3D treatment planning and dose calculation; a chest CT angiography for delineation of cardiac substructures; and a myocardial perfusion SPECT imaging to provide a map of regional myocardial perfusion and determine left ventricle ejection fraction (LVEF).
Treatment phase will consist of the standard course of breast radiotherapy in our department. The main difference will be in the delineation of the organ at risk, cardiac substructures will be delineated to obtain the dosimetry During the follow up period, patient will be scheduled to undergo cardiac SPECT before and at 3-, 6-, and 12-month period post irradiation. Stress ECG-gated SPECT will be performed after infusion of 3 MBq/kg 99mTc-tetrofosmin (Myoview®, General Electrics Healthcare) at peak pharmacological stress with regadenoson, (single dosage: 400 µg; Rapiscan®, GE healthcare)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with left sided breast cancer who are planned for | Experimental | Other: myocardial perfusion SPECTone of the following heart sparing techniques : * DIBH radiotherapy * IMRT |
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)
- Patient with left sided breast cancer histologically confirmed after lumpectomy or mastectomy with/without lymph node involvement who are planned for DIBH-RT or IMRT
- Age > 18 years
- Karnofsky Performance Status (KPS) > 60%
- Absence of psychiatric illness hindering follow-up
- Patient understands French
Key exclusion criteria (5 listed)
- Bilateral breast cancer
- History of thoracic irradiation
- Pregnancy or breastfeeding
- Any medical contraindication of cardiac SPECT or chest CT angiography.
- Any medical contraindication of Regadenoson
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 |
|---|---|---|
| myocardial perfusion SPECTFor all participants, myocardial perfusion SPECT will be performed : at 3, 6 and 12 months (post irradiation) | Other | Patients with left sided breast cancer who are planned for |
Primary outcome
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
Time frame: at 3 months from the end of radiotherapy
Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
Time frame: at 6 months from the end of radiotherapy
Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
Time frame: at 12 months from the end of radiotherapy
Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
8 secondary outcomes
Assession of wall-motion abnormalities and left ventricular ejection fraction (LVEF) decrease
Time frame: up to 12 months from the end of radiotherapy
Assessing the relevance of mean heart dose in the prevention of Radiation-induced heart disease (RIHD) compared to cardiac substructures.
Time frame: up to 12 months from the end of radiotherapy
Influence of cardiac risk factors on post-radiation myocardial perfusion.
Time frame: up to 12 months from the end of radiotherapy
Influence of anticancer therapy exposure on post-radiation myocardial perfusion
Time frame: up to 12 months from the end of radiotherapy
Influence of anticancer therapy exposure on post-radiation myocardial perfusion
Time frame: up to 12 months from the end of radiotherapy
Influence of anticancer therapy exposure on post-radiation myocardial perfusion
Time frame: up to 12 months from the end of radiotherapy
Impact of the location of the tumor bed boost on the cardiac dose.
Time frame: up to 12 months from the end of radiotherapy
Impact of the location of the tumor bed boost on the cardiac dose.
Time frame: up to 12 months from the end of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 16360786Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
- Background: PubMed 28529208Cheng YJ, Nie XY, Ji CC, Lin XX, Liu LJ, Chen XM, Yao H, Wu SH. Long-Term Cardiovascular Risk After Radiotherapy in Women With Breast Cancer. J Am Heart Assoc. 2017 May 21;6(5):e005633. doi: 10.1161/JAHA.117.005633.
- Background: PubMed 23484825Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.
- Background: PubMed 28319436Taylor C, Correa C, Duane FK, Aznar MC, Anderson SJ, Bergh J, Dodwell D, Ewertz M, Gray R, Jagsi R, Pierce L, Pritchard KI, Swain S, Wang Z, Wang Y, Whelan T, Peto R, McGale P; Early Breast Cancer Trialists' Collaborative Group. Estimating the Risks of Breast Cancer Radiotherapy: Evidence From Modern Radiation Doses to the Lungs and Heart and From Previous Randomized Trials. J Clin Oncol. 2017 May 20;35(15):1641-1649. doi: 10.1200/JCO.2016.72.0722. Epub 2017 Mar 20.
- Background: PubMed 17547777Nieder C, Schill S, Kneschaurek P, Molls M. Influence of different treatment techniques on radiation dose to the LAD coronary artery. Radiat Oncol. 2007 Jun 5;2:20. doi: 10.1186/1748-717X-2-20.
- Background: PubMed 26867877Boda-Heggemann J, Knopf AC, Simeonova-Chergou A, Wertz H, Stieler F, Jahnke A, Jahnke L, Fleckenstein J, Vogel L, Arns A, Blessing M, Wenz F, Lohr F. Deep Inspiration Breath Hold-Based Radiation Therapy: A Clinical Review. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):478-92. doi: 10.1016/j.ijrobp.2015.11.049. Epub 2015 Dec 17.
- Background: PubMed 27648167Lauche O, Kirova YM, Fenoglietto P, Costa E, Lemanski C, Bourgier C, Riou O, Tiberi D, Campana F, Fourquet A, Azria D. Helical tomotherapy and volumetric modulated arc therapy: New therapeutic arms in the breast cancer radiotherapy. World J Radiol. 2016 Aug 28;8(8):735-42. doi: 10.4329/wjr.v8.i8.735.
- Background: PubMed 35165015Eber J, Leroy-Freschini B, Antoni D, Noel G, Pflumio C. Increased cardiac uptake of (18F)-fluorodeoxyglucose incidentally detected on positron emission tomography after left breast irradiation: How to interpret? Cancer Radiother. 2022 Sep;26(5):724-729. doi: 10.1016/j.canrad.2021.10.010. Epub 2022 Feb 12.
- Background: PubMed 16111592Marks LB, Yu X, Prosnitz RG, Zhou SM, Hardenbergh PH, Blazing M, Hollis D, Lind P, Tisch A, Wong TZ, Borges-Neto S. The incidence and functional consequences of RT-associated cardiac perfusion defects. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):214-23. doi: 10.1016/j.ijrobp.2005.01.029.
- Background: PubMed 9143466Gyenes G, Fornander T, Carlens P, Glas U, Rutqvist LE. Detection of radiation-induced myocardial damage by technetium-99m sestamibi scintigraphy. Eur J Nucl Med. 1997 Mar;24(3):286-92. doi: 10.1007/BF01728765.
- Background: PubMed 22067743Sioka C, Exarchopoulos T, Tasiou I, Tzima E, Fotou N, Capizzello A, Ragos V, Tsekeris P, Fotopoulos A. Myocardial perfusion imaging with (99 m)Tc-tetrofosmin SPECT in breast cancer patients that received postoperative radiotherapy: a case-control study. Radiat Oncol. 2011 Nov 8;6:151. doi: 10.1186/1748-717X-6-151.
- Background: PubMed 12208576Seddon B, Cook A, Gothard L, Salmon E, Latus K, Underwood SR, Yarnold J. Detection of defects in myocardial perfusion imaging in patients with early breast cancer treated with radiotherapy. Radiother Oncol. 2002 Jul;64(1):53-63. doi: 10.1016/s0167-8140(02)00133-0.
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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 myocardial perfusion SPECT in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe 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 5 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 29 Nov 2022. 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 Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy (time frame: at 3 months from the end of radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454553, which also lists 20 linked publications.
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 29 Nov 2022.