Clinical trial · Interventional
Combined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung Tumors in Close Proximity to the Chest Wall
NCT04507828CI-TRIAL-00087941completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate a new radiation planning and treatment delivery technique called Deep Inspiration Breath Hold (DIBH) and expiration technique. This technique will be used to treat patients who have tumors close to the chest wall and are candidates for Stereotactic Body Radiation Therapy (SBRT). This study will assess the reduction of radiation to the chest wall during treatment using this technique.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment Planning using the DIBH Technique | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined DIBH-Expiration Planning Technique
- description
- Patients will undergo a 4D scan as well as a DIBH scan and an expiration breath hold scan. In order to develop a combined DIBH-Expiration treatment plan, the DIBH scan, the expiration phase of the 4D scan or the expiration breath hold scan will be used. If the radiation plan meets the coverage goals and normal tissue constraints, the patient will receive treatment using the new DIBH Planning Technique. If coverage and normal tissue constraints are not met per protocol, the patient will be treated per standard of care and not on protocol. Patients treated on protocol will undergo radiation treatment with SBRT for a total of 3 fractions and will receive each fraction no more frequently then every other day. Patients will then be evaluated at 1 month after SBRT completion and every 3 months for 2 years
- interventionNames
- Radiation: Treatment Planning using the DIBH Technique
Primary outcomes (1)
- measure
- Reduction in chest wall V30 using combined DIBH-expiration planning technique
- timeFrame
- 2 weeks (SBRT planning)
- description
- The percentage of patients with an at least 50% reduction in chest wall V30 using combined DIBH-expiration planning technique in comparison to DIBH or expiration gating alone in the same patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≥ 18 at time of consent 2. Karnofsky Performance Status (KPS) \> 40 3. Ability to provide written informed consent and HIPAA authorization 4. Clinical or pathological diagnosis of primary lung cancer or metastasis to the lung 5. Tumors must be located within 2 cm from the chest wall, defined as the inner border of the 2-cm lung expansion volume (per TG101) 6. Plan to receive Lung SBRT Exclusion Criteria: 1. Patients with tumors with \> 50% overlap between respiratory states based on CT simulation will not be eligible for this study 2. Previous radiation therapy to the same site per investigator discretion 3. Inability to comply with treatment or standard of care follow up per investigator discretion
References
Publications (0)
Data not yet available
No reference posted for this study.