DIBH Technique for Lung Cancer

Overseen By Nikki Barrow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Previous radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

4 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tim Lautenschlager, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 with lung cancer or lung metastasis, whose tumors are close to the chest wall and who can undergo Stereotactic Body Radiation Therapy (SBRT). Participants must be able to consent and have a performance status indicating they can carry out daily activities. Those previously treated with radiation at the same site or unable to follow treatment plans are excluded.

Inclusion Criteria

I can care for myself but may not be able to do active work.

I have been diagnosed with lung cancer or cancer that has spread to my lungs.

Ability to provide written informed consent and HIPAA authorization

Exclusion Criteria

Patients with tumors with > 50% overlap between respiratory states based on CT simulation will not be eligible for this study

Inability to comply with treatment or standard of care follow up per investigator discretion

I have had radiation therapy to the same area before, as approved by my doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SBRT Planning

SBRT planning using combined DIBH-expiration technique to reduce chest wall V30

2 weeks

Treatment

Participants receive SBRT treatment with the new DIBH Planning Technique for a total of 3 fractions

8 weeks

3 visits (in-person), each fraction no more frequently than every other day

Follow-up

Participants are evaluated at 1 month after SBRT completion and every 3 months for 2 years

2 years

1 visit (in-person) at 1 month, then every 3 months

Treatment Details

Interventions

• Treatment Planning using the DIBH Technique

Trial Overview The study tests a new radiation technique called Deep Inspiration Breath Hold (DIBH) combined with expiration planning in treating patients with lung tumors near the chest wall. It aims to minimize radiation exposure to the chest wall during SBRT treatments.

Participant Groups

Group I: Combined DIBH-Expiration Planning Technique Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+