Efficacity of Deep Inspiration Breath Hold and Intensity-modulated Radiotherapy in Preventing PErfusion Defect for Left Sided Breast Cancer (EDIPE)

NCT05454553 | Unknown

• 2 other identifiers: 2021-012ID-RCB
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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

Breast Cancer

Keywords

Breast Cancer; Cardiac Toxicity; Deep Inspiration Breath Hold; Myocardial Perfusion Imaging

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  at 12 months from the end of radiotherapy

Secondary Outcomes (8)

• Assession of wall-motion abnormalities and left ventricular ejection fraction (LVEF) decrease

  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.

  up to 12 months from the end of radiotherapy

• Influence of cardiac risk factors on post-radiation myocardial perfusion.

  up to 12 months from the end of radiotherapy

• Influence of anticancer therapy exposure on post-radiation myocardial perfusion

  up to 12 months from the end of radiotherapy

• Influence of anticancer therapy exposure on post-radiation myocardial perfusion

  up to 12 months from the end of radiotherapy

Study Arms (1)

Patients with left sided breast cancer who are planned for

EXPERIMENTAL

one of the following heart sparing techniques : * DIBH radiotherapy * IMRT

Other: myocardial perfusion SPECT

Interventions

myocardial perfusion SPECT OTHER

For all participants, myocardial perfusion SPECT will be performed : at 3, 6 and 12 months (post irradiation)

Patients with left sided breast cancer who are planned for

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Valérie SARTORI

CONTACT

368767223; v.sartori@icans.eu

Manon VOEGELIN

CONTACT

368339523; promotion-rc@icans.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 12, 2022
• Study Start: October 27, 2022
• Primary Completion: October 27, 2024
• Study Completion: October 27, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

FR (1)