Motion-Corrected Cone-Beam CT for Lung Cancer

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

17 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Motion-Corrected Cone-Beam CT for Lung Cancer?

Research shows that using cone-beam CT (a type of 3D imaging) for guiding stereotactic body radiation therapy (a precise form of radiation treatment) in lung cancer helps accurately target tumors, improving treatment precision and potentially leading to better outcomes. ^{1 2 3 4 5}

Is Motion-Corrected Cone-Beam CT for Lung Cancer safe for humans?

Research on similar treatments, like stereotactic body radiation therapy (SBRT) using cone-beam CT, shows it is generally safe, but there can be side effects like radiation pneumonitis (lung inflammation). Safety data from these studies suggest that while the treatment is effective, monitoring for adverse events is important. ^{1 5 6 7 8}

How is Motion-Corrected Cone-Beam CT for Lung Cancer different from other treatments?

This treatment uses advanced imaging techniques to track and adjust for tumor movement caused by breathing, allowing for more precise targeting of radiation therapy. This reduces the risk of damaging healthy tissue and improves the accuracy of delivering radiation to lung tumors compared to traditional methods. ^{2 9 10 11 12}

What is the purpose of this trial?

The first purpose of this study is to test a new computer program that reduces the blurring in the cone-beam CT scan and helps the doctor to better locate the tumor. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way we treat the cancer in the lungs. The second purpose of this study is to test how well this computer program tracks markers in the images, compared to using radio signals to follow the markers.

Research Team

Zhang Peng, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A collaborative analysis of stereotactic lung radiotherapy outcomes for early-stage non-small-cell lung cancer using daily online cone-beam computed tomography image-guided radiotherapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cone-beam computed tomography for on-line image guidance of lung stereotactic radiotherapy: localization, verification, and intrafraction tumor position. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Image-guided radiotherapy via daily online cone-beam CT substantially reduces margin requirements for stereotactic lung radiotherapy. [2022]

4. Singapore pubmed.ncbi.nlm.nih.gov

Influence of tumor characteristics on correction differences between cone-beam computed tomography-guided patient setup strategies in stereotactic body radiation therapy for lung cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Dosimetric impact of online correction via cone-beam CT-based image guidance for stereotactic lung radiotherapy. [2016]

6. United States 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. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

3D dose delivery verification using repeated cone-beam imaging and EPID dosimetry for stereotactic body radiotherapy of non-small cell lung cancer. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Dose--volume metrics associated with radiation pneumonitis after stereotactic body radiation therapy for lung cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Motion-aware temporal regularization for improved 4D cone-beam computed tomography. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Respiratory correlated cone beam CT. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Calculating tumor trajectory and dose-of-the-day using cone-beam CT projections. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Respiratory motion estimation from slowly rotating x-ray projections: theory and simulation. [2017]