Combined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung Tumors in Close Proximity to the Chest Wall

NCT04507828 | Completed DMC

• 1 other identifier: RAON-IIR-IUSCC-0711
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer; Metastatic Cancer

Keywords

Radiation Treatment; Lung Cancer; Metastatic Cancer; Stereotactic Body Radiation Therapy (SBRT)

Outcome Measures

Primary Outcomes (1)

• Reduction in chest wall V30 using combined DIBH-expiration planning technique

  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

  2 weeks (SBRT planning)

Secondary Outcomes (7)

• Patients treated using DIBH planning technique

  8 weeks (treatment with SBRT)

• Chest wall toxicity

  1 year

• Rib fracture

  1 year

• Local control rate

  2 year

• Time in treatment room

  8 weeks (completion of SBRT)

Study Arms (1)

Combined DIBH-Expiration Planning Technique

EXPERIMENTAL

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

Radiation: Treatment Planning using the DIBH Technique

Interventions

Treatment Planning using the DIBH Technique RADIATION

Different radiation plans will be generated-one using a DIBH scan with corresponding target and normal tissue contour and a second using an expiration scan with corresponding target and normal tissue contours. The expiration scan can be an expiratory gating scan averaging the expiratory breathing phases or an expiration breath hold scan as determined based on patient performance during simulation and relative tumor displacement compared to the DIBH scan. Then a third plan will be generated conceptually combining the two previous plans, named the DIBH-expiration composite plan.

Combined DIBH-Expiration Planning Technique

Eligibility Criteria

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

You may qualify if:

• Age≥ 18 at time of consent
• Karnofsky Performance Status (KPS) \> 40
• Ability to provide written informed consent and HIPAA authorization
• Clinical or pathological diagnosis of primary lung cancer or metastasis to the lung
• 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)
• Plan to receive Lung SBRT

You may not qualify if:

• Patients with tumors with \> 50% overlap between respiratory states based on CT simulation will not be eligible for this study
• Previous radiation therapy to the same site per investigator discretion
• Inability to comply with treatment or standard of care follow up per investigator discretion

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital / IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim Lautenschlager, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: October 2, 2020
• Primary Completion: February 16, 2023
• Study Completion: December 30, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)