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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for planning and delivering radiation treatments for lung cancer using a technique called Deep Inspiration Breath Hold (DIBH). The researchers aim to determine if this technique can reduce the radiation reaching the chest wall during treatment, potentially protecting healthy tissue. It targets individuals with lung cancer whose tumors are near the chest wall and who are scheduled to receive Stereotactic Body Radiation Therapy (SBRT). Ideal participants have tumors less than 2 cm from the chest wall and have not previously received radiation to the same site. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future lung cancer treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the DIBH technique is safe for lung cancer treatment?

Research has shown that the Deep Inspiration Breath Hold (DIBH) technique is safe and generally easy for patients to use in lung cancer treatment. Studies have found that DIBH can clarify imaging and reduce treatment uncertainties, enabling doctors to target the tumor more accurately. This technique also reduces tumor movement and shifts the heart, protecting healthy lung tissue during radiation.

In one study, researchers successfully used DIBH in 53 lung cancer patients. Only three patients experienced difficulty with the breath-hold process, indicating that most people can manage it well. These findings suggest that the DIBH technique is generally safe and manageable for patients receiving radiation therapy. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the DIBH Technique for lung cancer because it offers a more precise way to target tumors while minimizing damage to healthy tissue. Unlike traditional radiation therapy, which doesn't account for breathing motion, this technique uses a combination of scans to plan treatment around both deep inspiration breath holds and expiration phases, potentially improving accuracy. By refining how radiation is delivered, the DIBH Technique aims to enhance the effectiveness of treatment and reduce side effects, offering new hope for better outcomes in lung cancer care.

What evidence suggests that the DIBH technique is effective for lung cancer?

Research has shown that the Deep Inspiration Breath Hold (DIBH) technique in radiation therapy for lung cancer can enhance treatment precision. In this trial, participants will undergo a combined DIBH-Expiration Planning Technique, which includes a 4D scan, a DIBH scan, and an expiration breath hold scan. Studies have found that DIBH reduces the average radiation dose to the lungs by about 1.3 Gy, a measure of radiation. This technique also stabilizes the tumor and protects healthy tissues from radiation. A review of multiple studies found that DIBH significantly lowers the radiation dose to the heart. These findings suggest that DIBH can make radiation treatment safer and more effective for patients with lung tumors near the chest wall. ^{1 2 5 6 7}

Who Is on the Research Team?

Tim Lautenschlager, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5604920/

Deep inspiration breath-hold radiotherapy for lung cancer DIBH CBCT improved image quality and reduced registration uncertainty in the craniocaudal direction in image-guided RT of locally advanced lung cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405631624000605

Comparison of deep inspiration breath hold and free ... Deep inspiration breath hold reduced average lung dose by median 1.3 Gy. •. Inter-fraction target coverage robustness was comparable to free breathing. •. Risk ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02540499?cond=Deep%20inspiration%20breath-hold&viewType=Table&rank=5

Study Details | Deep Inspiration Breath Hold as Primary ... DIBH results in profound anatomic changes: tumour motion is minimised, the heart is drawn downward and the lungs are inflated and push the healthy away from the ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12992-2

Clinical benefits of deep inspiration breath-hold ... - BMC Cancer This meta-analysis demonstrates that the DIBH group achieved a significant reduction in heart dose (SMD = -0.63, 95% CI -0.85 to -0.41, P < 0.01) ...

5. redjournal.org redjournal.org/article/S0360-3016(09)02370-0/fulltext

A Dosimetric Comparison of Free-breathing (FB) and Deep ... Conclusions. DIBH improves target conformity index as well as heart and lung dosimetry in lung cancer patients treated with radiotherapy. The clinical ...

6. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02427-4

Protocol of a phase II study to evaluate the efficacy and safety ... DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6913352/

Deep inspiration breath hold in locally advanced lung cancer ... DIBH treatment plan was superior to FB plan in 53 patients, who proceeded with radiotherapy in DIBH. Three patients lost their DIBH compliance; this occurred ...