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L'essai clinique NCT07498855 (RADIANT) pour Cancer du sein est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation (RADIANT) 25 Observationnel Initié par l'investigateur
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L'essai clinique NCT07498855 (RADIANT) est une étude observationnel pour Cancer du sein. Son statut actuel est : en recrutement. L'étude a débuté le 1 octobre 2025 et vise à recruter 25 participants. Dirigée par Ruijin Hospital, l'étude devrait être terminée d'ici le 31 mai 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 mars 2026.
Résumé succinct
This study is an investigator-initiated, single-arm, single-center, prospective, observational study. The hypothesis is that during the implementation of deep inspiration breath-hold (DIBH) radiotherapy plans in postoperative breast cancer patients receiving internal mammary irradiation, the actual target dose coverage and organ-at-risk (OARs) dose parameters remain within clinically acceptable ranges.
Description détaillée
For patients with left-sided breast cancer, postoperative radiotherapy can expose the heart to excessive radiation, increasing the risk of cardiac toxicity. DIBH displaces the heart away from the chest wall by expanding the thoracic cavity during breath-holding to reduce cardiac radiation doses. Although DIBH has demonstrated efficacy in reducing cardiac exposure in left-sided breast cancer, its application in intern...Afficher plus
Titre officiel
Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Radiotherapy Plans for Internal Mammary Irradiation in Postoperative Breast Cancer
Pathologies
Cancer du seinAutres identifiants de l'étude
- RADIANT
- RJBC-DIBH
Numéro NCT
Date de début (réel)
2025-10-01
Dernière mise à jour publiée
2026-03-27
Date de fin (estimée)
2027-05-31
Inscription (estimée)
25
Type d'étude
Observationnel
Statut
En recrutement
Mots clés
DIBH
regional nodal irradiation
Internal Mammary Irradiation
Robustness Evaluation
Postoperative breast cancer radiotherapy
regional nodal irradiation
Internal Mammary Irradiation
Robustness Evaluation
Postoperative breast cancer radiotherapy
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Arm1: 3 mm Gating Window Group Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ±1.5 mm (a total of 3 mm). | DIBH with 3mm Gating Window The patient will receive moderately hypofractionated radiotherapy targeting the ipsilateral breast, supraclavicular and internal mammary nodes, and high-risk axillary region, with a prescribed dose of 40 Gy (RBE) /15Fx. IMRT, VMAT, or proton therapy will be chosen based on the radiation oncologist's judgment and patient preference.
Respiratory gating tolerance is set at ±1.5 mm (3 mm total). Three simulated CT scans...Afficher plus |
Arm2: 2 mm Gating Window Group Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ±1.0 mm (a total of 2 mm). | DIBH with 2 mm Gating Window The patient will receive moderately hypofractionated radiotherapy targeting the ipsilateral breast, supraclavicular and internal mammary nodes, and high-risk axillary region, with a prescribed dose of 40 Gy (RBE) /15Fx. IMRT, VMAT, or proton therapy will be chosen based on the radiation oncologist's judgment and patient preference. Respiratory gating tolerance is set at ±1 mm (2 mm total). Three simulated CT scans du...Afficher plus |
Arm3: 1.5 mm Gating Window Group Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ± 0.75 mm (a total of 1.5 mm). | DIBH with 1.5 mm Gating Window The patient will receive moderately hypofractionated radiotherapy targeting the ipsilateral breast, supraclavicular and internal mammary nodes, and high-risk axillary region, with a prescribed dose of 40 Gy (RBE) /15Fx. IMRT, VMAT, or proton therapy will be chosen based on the radiation oncologist's judgment and patient preference. Respiratory gating tolerance is set at ± 0.75 mm (1.5 mm total). Three simulated CT sc...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Target coverage of the Planning treatment volume (PTV) | Target coverage of the PTV, defined by V95% (the percentage of the PTV volume receiving at least 95% of the prescribed dose). | Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment. |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Additional dose-volume parameters of the PTV | PTV coverage as measured by V90%, and high-dose volume as measured by V105% and V110%. | Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment. |
Dose-volume parameters of the organs at risk (OARs) | The dose-volume histograms (DVHs) of OARs will be analyzed. The evaluation will cover:
Cardiac Structures: Mean dose, D1cc, and V2-V30 for the heart and left ventricle (LV), along with D0.1cc for the left anterior descending artery (LAD).
Lungs: Mean dose and V5-V25 for the left lung, and V2 and V4 for the right lung.
Serial Organs: Maximum dose for the spinal cord (Dmax), D0.1cc for the left brachial plexus, and D1cc for the esophagus.
Other Structures: Mean dose for the left humeral head, contralateral right breast, and thyroid gland. | Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment. |
Conformity Index (CI) of the PTV | Calculated as V95% / PTV volume. A value closer to 1 indicates better conformity. | Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment. |
Homogeneity Index (HI) of the PTV | Calculated as (D2% - D98%)/D50%. A lower value indicates better homogeneity. | Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment. |
Intra-fractional Error-PTV | Intra-fractional error is defined as any patient movement occurring during a single radiotherapy fraction, measured by surface-guided or image-guided systems. This outcome evaluates the impact of intra-fractional motion on target coverage using DVH-based metrics.
PTV Metrics include: V95%: percentage of PTV receiving ≥95% of prescribed dose, V90%: percentage of PTV receiving ≥90% of prescribed dose, High-dose volume: V105% and V110%, percentage of PTV receiving ≥105% or ≥110% of prescribed dose, HI: (D2% - D98%) / D50%, where D2%, D98%, D50% are doses covering 2%, 98%, and 50% of PTV, CI: (PTV volume covered by prescription dose)² / (PTV volume × prescription isodose volume). | During each treatment fraction (daily, approximately 3-4 weeks per patient) |
Intra-fractional Error-OARs | Intra-fractional error is defined as any patient movement occurring during a single radiotherapy fraction, measured by surface-guided or image-guided systems. This outcome evaluates the impact of intra-fractional motion on OAR doses using DVH-based metrics.
OAR Dose Metrics: Heart and LV: mean dose, D1cc, V2-V30, LAD : D0.1cc, Lungs: mean dose and V5-V25 for left lung, V2 and V4 for right lung, Spinal cord: Dmax, Left brachial plexus: D0.1cc, Esophagus: D1cc, Other relevant structures: mean dose for left humeral head, contralateral breast, thyroid gland, Unit of measurement: Gy for absolute doses; % for volume-based metrics. | During each treatment fraction (daily, approximately 3-4 weeks per patient) |
Inter-fractional Error- PTV | Inter-fractional error is defined as positional variation occurring between different treatment days, measured using daily CBCT image registration and dose recalculation. This outcome evaluates the impact of inter-fractional motion on PTV coverage using DVH metrics.
PTV Metrics include: V95%: percentage of PTV receiving ≥95% of prescribed dose, V90%: percentage of PTV receiving ≥90% of prescribed dose, High-dose volume: V105% and V110%, percentage of PTV receiving ≥105% or ≥110% of prescribed dose, HI: (D2% - D98%) / D50%, where D2%, D98%, D50% are doses covering 2%, 98%, and 50% of PTV, CI: (PTV volume covered by prescription dose)² / (PTV volume × prescription isodose volume). | Across all treatment fractions (approximately 3-4 weeks per patient) |
Inter-fractional Error- OAR | Inter-fractional error is defined as positional variation occurring between different treatment days, measured using daily CBCT image registration and dose recalculation. This outcome evaluates the impact of inter-fractional motion on OAR doses using DVH metrics.
OAR Dose Metrics: Heart and LV: mean dose, D1cc, V2-V30, LAD : D0.1cc, Lungs: mean dose and V5-V25 for left lung, V2 and V4 for right lung, Spinal cord: Dmax, Left brachial plexus: D0.1cc, Esophagus: D1cc, Other relevant structures: mean dose for left humeral head, contralateral breast, thyroid gland, Unit of measurement: Gy for absolute doses; % for volume-based metrics. | Across all treatment fractions (approximately 3-4 weeks per patient) |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
- Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.
- Female patients aged ≥ 18 years.
- Histologically confirmed invasive breast cancer.
- Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy and/or axillary lymph node dissection.
- Able to hold breath for more than 30 seconds after deep inspiration.
- Planned to receive postoperative radiotherapy targeting regional lymph nodes, including the internal mammary nodes, under DIBH conditions.
- Planned to undergo moderate hypofractionated radiotherapy.
- Karnofsky Performance Status (KPS) score ≥ 80.
- The estimated life expectancy of greater than 5 years .
- Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.
- Pregnant or breastfeeding women.
- Presence of any severe, uncontrolled comorbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results.
- Unable to understand or comply with breath-hold training instructions.
- Right-sided breast cancer.
Ruijin HospitalPartie responsable de l'étude
Lu Cao, Investigateur principal, Associate Professor, Ruijin Hospital
Contact central de l'étude
Contact: Lu Cao, PhD, +86-021-64370045, [email protected]
1 Centres de l'étude dans 1 pays
Shanghai Municipality
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, 200025, China
Lu Cao, PhD, Contact, 86-021-64370045, [email protected]
En recrutement