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Radiation Therapy

Guided Radiation Therapy for Lung Cancer

N/A

Waitlist Available

Led By Daphna Gelblum, MD

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

Patients must have histologic proof of malignancy suitable for thoracic radiation therapy

Age ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the use of beacon implants to help guide radiation therapy for lung cancer patients.

Who is the study for?

This trial is for adults over 18 with lung cancer suitable for radiation therapy, who can hold their breath for at least 20 seconds and tolerate a bronchoscopy. They should have a life expectancy of more than a year and be able to follow the study schedule. Excluded are those with metal implants in the chest, active devices like pacemakers, significant infections, hypersensitivity to nickel, or pregnant/nursing women.Check my eligibility

What is being tested?

The study tests Calypso beacon implants used during radiation treatment of lung tumors. These small devices help track tumor location as patients use Deep Inspiration Breath Hold (DIBH) technique during therapy to potentially improve treatment accuracy.See study design

What are the potential side effects?

Possible side effects include discomfort from the implantation procedure via bronchoscopy, potential allergic reactions if sensitive to materials like nickel in the beacons, and general risks associated with sedation or anesthesia required for implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I can hold my breath for more than 20 seconds, five times in a row.

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I can undergo a flexible bronchoscopy procedure.

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I can care for myself but may need occasional help.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

feasibility of Calypso transponders

Secondary outcome measures

measure the residual intrafraction tumor motion

reproducibility

Trial Design

1Treatment groups

Experimental Treatment

Group I: Calypso-based Deep Inspiration Breath Hold (DIBH)Experimental Treatment1 Intervention

This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies. Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,272 Total Patients Enrolled

Varian Medical SystemsIndustry Sponsor

59 Previous Clinical Trials

3,731 Total Patients Enrolled

Daphna Gelblum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

124 Total Patients Enrolled

Media Library

Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02111681 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Calypso-based Deep Inspiration Breath Hold (DIBH)

Non-Small Cell Lung Cancer Clinical Trial 2023: Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments Highlights & Side Effects. Trial Name: NCT02111681 — N/A

Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02111681 — N/A

Frequently Asked Questions

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

Is the process of signing up for this study still open?

"Clinicaltrials.gov indicates this trial is not currently accepting participants - the post was first made on April 1st, 2014 and then last edited on July 14th 2022. Despite that, there are still 1610 other medical studies actively enrolling patients at present."

Answered by AI

In how many distinct sites is this clinical experiment being implemented?

"This medical trial is currently recruiting from 4 different sites which include Memorial Sloan Kettering West Harrison in Harrison, Memorial Sloan Kettering Monmouth in Middletown, and Memorial Sloan Kettering Commack. There are several other locations participating as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

2014. "Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02111681.

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