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El ensayo clínico NCT07498855 (RADIANT) para Cáncer de mama está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation (RADIANT) 25 Observacional Iniciado por investigador
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El ensayo clínico NCT07498855 (RADIANT) es un estudio observacional para Cáncer de mama. Su estado actual es: reclutando. El estudio se inició el 1 de octubre de 2025, con el objetivo de reclutar a 25 participantes. Dirigido por Ruijin Hospital, se espera que finalice el 31 de mayo de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
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.
Descripción detallada
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...Mostrar más
Título oficial
Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Radiotherapy Plans for Internal Mammary Irradiation in Postoperative Breast Cancer
Condiciones médicas
Cáncer de mamaOtros ID del estudio
- RADIANT
- RJBC-DIBH
Número del NCT
Inicio del estudio (real)
2025-10-01
Última actualización
2026-03-27
Fecha de finalización (estimada)
2027-05-31
Inscripción (prevista)
25
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
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
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
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...Mostrar más |
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...Mostrar más |
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...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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) |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
- 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 HospitalParte responsable del estudio
Lu Cao, Investigador principal, Associate Professor, Ruijin Hospital
Contactos centrales del estudio
Contacto: Lu Cao, PhD, +86-021-64370045, [email protected]
1 Centros del estudio en 1 países
Shanghai Municipality
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, 200025, China
Lu Cao, PhD, Contacto, 86-021-64370045, [email protected]
Reclutando