Motion-Corrected Cone-Beam CT for Lung Cancer

Not currently recruiting at 3 trial locations

Overseen By Andreas Rimner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active infections, Bronchiectasis, Nickel allergy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new computer program designed to reduce blurring in cone-beam CT scans, helping doctors accurately locate lung tumors. It also compares the program's ability to track markers in images against the use of radio signals. The trial includes patients undergoing stereotactic body radiation treatments, a precise form of radiation therapy, for lung cancer. Individuals with lung cancer planning to receive radiation therapy may be suitable candidates, particularly if part of their tumor is visible on a CT scan and they can have specific markers placed in their lungs. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future lung cancer treatments.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this computer program is safe for use in lung cancer treatment?

Research shows that Stereotactic Body Radiation Treatments (SBRT) for lung cancer are usually well tolerated, though some risks exist. Studies have found that SBRT can cause serious side effects in about 10% to 30% of patients, including severe lung inflammation or pneumonia. In rare cases, deaths related to the treatment have occurred. However, many patients complete the treatment without major issues. The safety of SBRT is considered acceptable compared to other treatments for lung tumors. Discuss any concerns with the medical team to understand how these findings might relate to your health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about motion-corrected cone-beam CT (CBCT) for lung cancer because it aims to enhance the accuracy of stereotactic body radiation therapy (SBRT). Unlike traditional imaging techniques, this approach compensates for respiratory motion, potentially leading to more precise targeting of tumors and sparing healthy tissue. This could improve patient outcomes by reducing side effects and increasing the effectiveness of radiation treatments. Ultimately, the hope is that this method will lead to better control of lung cancer while minimizing the impact on a patient's quality of life.

What evidence suggests that this computer program is effective for improving lung cancer treatment?

Research has shown that stereotactic body radiation therapy (SBRT), which participants in this trial will receive, effectively treats lung cancer. Studies have found that it can completely control cancer in the treated area for at least six months, with no serious side effects in some cases. Real-world evidence also supports SBRT's success in managing cancerous lung spots, providing good results with generally manageable side effects. Over the long term, SBRT offers survival rates similar to surgery for early-stage lung cancer, with 69% of patients surviving more than eight years. These findings suggest that SBRT is a strong option for treating lung cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Zhang Peng, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed lung malignancies suitable for radiation therapy, who are planning to undergo such treatment. They must have a visible part of the tumor on CT scans and be in relatively good health (Karnofsky Performance Status ≥ 60%). They should be able to have small markers placed in their lungs via bronchoscopy.

Inclusion Criteria

I can care for myself but may need occasional help.

I can have a procedure to place tracking devices in my lungs, as shown by a recent CT scan.

I am planning to undergo radiation therapy for lung cancer or cancer that has spread to the lung.

Exclusion Criteria

I cannot safely have a bronchoscopy according to hospital rules.

I currently have a serious infection.

I cannot safely undergo anesthesia or sedation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants undergo radiation treatment with respiratory motion-corrected cone-beam CT and intratreatment gating based on electromagnetic transponders

6-8 weeks

Daily for SBRT, weekly for standard fractionation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including history and physical exam, diagnostic CT chest, and toxicity assessment

24 months

Visits at 3, 6, 9, 12, 15, 18, 21, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bronchoscopic Implantation
• Cone-Beam CT-Guided
• Stereotactic Body Radiation Treatments

Trial Overview The study is testing a new computer program that aims to reduce blurring on cone-beam CT scans used during lung cancer treatments. It will compare how well this program locates tumors against another method using radio signals to track implanted markers during stereotactic body radiation treatments.

How Is the Trial Designed?

Group I: Patients with lung cancer Experimental Treatment 3 Interventions

Physician evaluation of patient setup accuracy will be performed using all available images and adjustments will be made as per standard practice. In addition, a respiration motion-corrected CBCT (daily for SBRT, weekly for standard fractionation) will be used to confirm the accuracy of Calypso-based setup. Patients will return for follow up at 3,6, 9, 12, 15, 18, 21 and 24 months (+/- 4 weeks) following completion of radiation therapy. The following assessments will be performed at these visits: history and physical exam, diagnostic CT chest, and toxicity assessment.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a randomized phase 2 trial involving 98 medically inoperable patients with early-stage non-small cell lung cancer, a single fraction of 30 Gy was found to be as effective as 60 Gy delivered in three fractions regarding toxicity and cancer control outcomes.

Patients receiving the single fraction treatment reported better social functioning and less dyspnea at the 6-month follow-up, suggesting that 30 Gy in 1 fraction may improve quality of life compared to the 60 Gy in 3 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. Singh, AK., Gomez-Suescun, JA., Stephans, KL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6318482/

Stereotactic body radiation therapy for non-small cell lung ... No differences in outcomes were observed between conventionally fractionated radiation therapy and SBRT, central and peripheral lung tumors, or inoperable and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1879850024002753

Stereotactic Body Radiation Therapy for Primary Lung ... Six-month LC was 100%, and no acute grade 3+ toxicity was observed. A separate retrospective study examined 50 patients with high-risk lung tumors (29 primary ...

3. ascopubs.org ascopubs.org/doi/10.1200/GO.22.00061

Real-World Evidence of Health Outcomes Related to Lung ... Our results indicate that SBRT is effective (high local control and acceptable toxicity) for treating malignant lung lesions in a real-world scenario in Latin ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02699-4

A prospective outcomes and cost-effective analysis of surgery ... Treatment outcomes in stage I lung cancer: A comparison of surgery and stereotactic body radiation therapy. J Thorac Oncol. 2015;10:1776–84 ...

5. news-medical.net news-medical.net/news/20250926/Stereotactic-body-radiation-therapy-and-surgery-show-similar-outcomes-for-early-lung-cancer.aspx

Stereotactic body radiation therapy and surgery show ... At a median follow-up of 8.3 years, overall survival rates were 69% for the SBRT cohort and 66% for the surgery cohort, a difference that was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6460233/

Long-term Clinical Outcomes and Safety Profile of SBRT for ... SBRT for central lung tumors offers very high rates of LC and acceptable rates of severe toxicity comparable with peripheral tumors.

7. redjournal.org redjournal.org/article/S0360-3016(24)00508-X/fulltext

Safety and Efficacy of Stereotactic Body Radiation Therapy ... There was 1 possible treatment-related death from pneumonitis/pneumonia. Predictors of severe toxicity included increased PTV size, decreased ...

8. tlcr.amegroups.org tlcr.amegroups.org/article/view/43005/html

Four-year follow-up outcomes after stereotactic body radiation ... Conclusions: SBRT with a BED 100 Gy in 4–10 fractions is effective and acceptable for treating patients with central early-stage NSCLC. Further studies are ...

9. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00275-3/fulltext

Stereotactic Body Radiation Therapy for Primary Lung ... Data informing the safety, efficacy, treatment logistics, and dosimetry of stereotactic body radiation therapy (SBRT) for lung tumors has ...