Lung CancerNCT02434809
Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
A study testing Bronchoscopic Implantation, Cone-Beam CT-Guided and stereotactic body radiation treatments in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bronchoscopic Implantation, Cone-Beam CT-Guided and stereotactic body radiation treatments
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic proof of malignancy suitable for thoracic radiation therapy
- Patient is planning to undergo radiation therapy for primary or recurrent malignancies of the lung or metastatic malignancies to the lung.
- Age ≥ 18 years old
- Karnofsky Performance Status ≥ 60%
- At least part of the tumor must be visible as observed in a diagnostic or planning CT.
- Able to have bronchoscopic placement of Calypso transponders as confirmed on a recent (within the past 8 weeks) CT scan.
Who cannot join
- Patients with clinically significant active infections.
- Bronchiectasis in the region of the intended implantation.
- History of hypersensitivity to nickel.
- Other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
- Deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines
- Unable to tolerate anesthesia or sedation
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- Enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
- Female patients who are pregnant or nursing
- Implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
- Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
- Patients whose lung tumors are being monitored by MR imaging as part of standard clinical care. Implantation of transponders will degrade MR images.
- Posterior lesions that would be >19 cm distance from Calypso detector plate.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Cancer Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Investigation of Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
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.
- Conditions
- Lung Cancer
- Being tested
- Bronchoscopic Implantation, Cone-Beam CT-Guided, stereotactic body radiation treatments
- Keywords
- Respiratory Motion-Corrected Cone-Beam CT, Radiation, 14-225
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic ImplantationProcedure or surgery
Calypso transponders
Cone-Beam CT-GuidedDevice
stereotactic body radiation treatmentsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung cancer | Experimental | 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. Receives: Procedure: Bronchoscopic Implantation; Device: Cone-Beam CT-Guided; Radiation: stereotactic body radiation treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful Calypso transponder implantation
The RapidTrack algorithm will be considered successful if the centroid position of the Calypso transponders, as determined by the RapidTrack algorithm, are within 2 mm of the positions determined by the Calypso system 95% of the time.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Peng, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434809
- Sponsor's protocol ID
- 14-225
- Status last verified
- May 2026
- First submitted
- 30 Apr 2015
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
- ClinicalTrials.gov ID
- NCT02434809
- Acronym / sponsor ID
- 14-225
- Conditions
- Lung Cancer
- Keywords
- Respiratory Motion-Corrected Cone-Beam CT, Radiation, 14-225
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung cancer | Experimental | Procedure: Bronchoscopic Implantation, Device: Cone-Beam CT-Guided, Radiation: stereotactic body radiation treatmentsPhysician 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologic proof of malignancy suitable for thoracic radiation therapy
- Patient is planning to undergo radiation therapy for primary or recurrent malignancies of the lung or metastatic malignancies to the lung.
- Age ≥ 18 years old
- Karnofsky Performance Status ≥ 60%
- At least part of the tumor must be visible as observed in a diagnostic or planning CT.
Key exclusion criteria (12 listed)
- Patients with clinically significant active infections.
- Bronchiectasis in the region of the intended implantation.
- History of hypersensitivity to nickel.
- Other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
- Deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic ImplantationCalypso transponders | Procedure or surgery | Patients with lung cancer |
| Cone-Beam CT-Guided | Device | Patients with lung cancer |
| stereotactic body radiation treatments | Radiation | Patients with lung cancer |
Primary outcome
successful Calypso transponder implantation
Time frame: 1 year
The RapidTrack algorithm will be considered successful if the centroid position of the Calypso transponders, as determined by the RapidTrack algorithm, are within 2 mm of the positions determined by the Calypso system 95% of the time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Peng, PhD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic Implantation, Cone-Beam CT-Guided and stereotactic body radiation treatments in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful Calypso transponder implantation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.