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Radiation Therapy

DIBH Technique for Lung Cancer

N/A
Waitlist Available
Led By Tim Lautenschlager, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status (KPS) > 40
Clinical or pathological diagnosis of primary lung cancer or metastasis to the lung
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Summary

This trial is testing a new way to deliver radiation that may limit side effects for people with tumors near the chest wall.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of DIBH aren't detailed here, general risks may include discomfort from holding breath during treatment, potential for increased anxiety, and typical side effects associated with SBRT like skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do active work.
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I have been diagnosed with lung cancer or cancer that has spread to my lungs.
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I am 18 years old or older.
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My tumor is close to the chest wall, within 2 cm.
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I am planning to undergo a specialized lung radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in chest wall V30 using combined DIBH-expiration planning technique
Secondary study objectives
Chest wall toxicity
Evaluate lung dose
Local control rate
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combined DIBH-Expiration Planning TechniqueExperimental Treatment1 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

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,211 Total Patients Enrolled
Tim Lautenschlager, MDPrincipal InvestigatorIndiana University

Media Library

Treatment Planning using the DIBH Technique (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04507828 — N/A
~1 spots leftby Sep 2025
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