Clinical trial · Interventional
Efficacity of Deep Inspiration Breath Hold and Intensity-modulated Radiotherapy in Preventing PErfusion Defect for Left Sided Breast Cancer (EDIPE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| myocardial perfusion SPECT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with left sided breast cancer who are planned for
- description
- one of the following heart sparing techniques : * DIBH radiotherapy * IMRT
- interventionNames
- Other: myocardial perfusion SPECT
Primary outcomes (3)
- measure
- Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
- timeFrame
- at 3 months from the end of radiotherapy
- description
- Incidence of perfusion defects on follow-up myocardial perfusion SPECT scans
- measure
- Evaluation of DIBH and IMRT efficacy in preventing perfusion defect for left-sided breast cancer after radiotherapy
- timeFrame
- at 6 months from the end of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (20)
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- BACKGROUNDDarby 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. PMID 23484825
- BACKGROUNDTaylor 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. PMID 28319436
- BACKGROUNDNieder 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. PMID 17547777
- BACKGROUNDBoda-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.