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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,157 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still able to join this trial?

"Per the information on clinicaltrials.gov, this research study is currently recruiting participants; it was initially published on September 22nd 2020 and its details were recently updated on September 14th 2022."

Answered by AI

What is the capacity of this trial in regards to participants?

"Indeed, clinicaltrials.gov confirms that this investigation is still actively recruiting test subjects. The trial was first posted on September 22nd 2020 and its parameters have been recently modified on the 14th of September 2022. Forty volunteers need to be enrolled at one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Tim Lautenschlaeger 2020. "Combined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung Tumors in Close Proximity to the Chest Wall". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04507828.

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