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Radiation Therapy

Motion-Corrected Cone-Beam CT for Lung Cancer

N/A

Waitlist Available

Led By Michael Lovelock, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Status ≥ 60%

Age ≥ 18 years old

Must not have

Deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines

Unable to tolerate anesthesia or sedation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new computer program that may help doctors better locate tumors in cone-beam CT scans. The effects of this program on patients and cancer treatment will be studied. Additionally, the program will be compared to radio signals in tracking markers in images.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from bronchoscopic implantation like infection or bleeding, reactions related to anesthesia or sedation, and discomfort from the placement of electromagnetic transponders.

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 need occasional help.

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I am 18 years old or older.

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

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My cancer is confirmed and can be treated with chest radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot safely have a bronchoscopy according to hospital rules.

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I cannot safely undergo anesthesia or sedation.

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I currently have a serious infection.

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I have bronchiectasis where the implant is supposed to go.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 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

successful Calypso transponder implantation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with lung cancerExperimental Treatment3 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.

0 / 9Eligibility criteria met