Lung CancerNCT02695680
Lung SBRT Motion Management (GCC 1619)
An observational study of Lung Cancer, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2017to 4 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with primary or metastatic lung lesions
Who may be able to join
- Eligible disease(s)/stage(s) - Patients with primary or metastatic lung lesions to be treated using stereotactic body radiotherapy (SBRT) will be eligible for this study.
- Allowable type and amount of prior therapy - Any types and amounts of prior therapy will be allowed for this study.
- Age restriction and/or gender/ethnic restrictions - Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
- Life expectancy restrictions - None.
- ECOG or Karnofsky Performance Status - Karnofsky performance status of 50 or greater
- Requirements for organ and marrow function - None.
- Ability to understand and the willingness to sign a written informed consent document.
- Tumor motion > 5 mm, maximum GTV dimension < 50 mm - per guidelines established by the AAPM Task Group 7612 and RTOG 0236.13
Who cannot join
- Children (age <18)
- Women who are pregnant or trying to get pregnant
- Pain in supine position
- Karnofsky performance status < 50
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ummc Msgcc
Baltimore, Maryland, 21201
Upper Chesapeake Health
Bel Air, Maryland, 21014
About this study
Official title: Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT
Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). A patient-specific 4D model will be developed using the raw 4DCT projections time-correlated with real-time surface monitoring. In addition, before delivering each dose fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions, time-correlated with optical surface monitoring. The acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.
Read the detailed description
Surface monitoring procedure -The procedure is expected to last approximately 15 minutes after the end of the 4DCT scan, which is the standard-of-care for lung SBRT treatments at our institution. The procedure will consist of real-time surface tracking using the VisionRT system of the thoracic and/or abdominal region. Continuous audiovisual contact will be maintained with the subject during scanning. Each individual will be informed that they can stop the procedure at any point.
Fluoroscopic imaging procedure - Fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. Three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kV imager. Audiovisual contact will be maintained at all times with the patient.
Data collection and management: An ID number will be assigned to each separate patient, and the correlation between ID number and patient name and medical record number will be kept in a password-protected file in Dr. Amit Sawant's office. The database of information extracted from the medical record and radiation treatment records for each patient will be stored in an Excel file on a computer with password protection. All image data will be de-identified by Dr. Sawant before his research team analyzes them.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, SBRT, Motion Management
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung SBRT | Respiratory motion causes significant geometric and dosimetric errors in the administration of lung stereotactic radiotherapy (SBRT). The purpose of this study is to create and validate patient-specific motion models of the thoracic anatomy with high spatial and temporal resolution. These models will be used to develop novel four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who demonstrate significant motion movement during radiation therapy.
Develop novel Four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start27 Oct 2017
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Why it stopped: Funding for this study is over and the PI has request closure.
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 University of Maryland, BaltimoreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Amit Sawant, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695680
- Sponsor's protocol ID
- HP-00068540
- Status last verified
- May 2024
- First submitted
- 18 Feb 2016
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT
- ClinicalTrials.gov ID
- NCT02695680
- Acronym / sponsor ID
- HP-00068540
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, SBRT, Motion Management
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding for this study is over and the PI has request closure.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 1 Mar 2016 (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.
Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). A patient-specific 4D model will be developed using the raw 4DCT projections time-correlated with real-time surface monitoring. In addition, before delivering each dose fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions, time-correlated with optical surface monitoring. The acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.
Detailed description
Surface monitoring procedure -The procedure is expected to last approximately 15 minutes after the end of the 4DCT scan, which is the standard-of-care for lung SBRT treatments at our institution. The procedure will consist of real-time surface tracking using the VisionRT system of the thoracic and/or abdominal region. Continuous audiovisual contact will be maintained with the subject during scanning. Each individual will be informed that they can stop the procedure at any point.
Fluoroscopic imaging procedure - Fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. Three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kV imager. Audiovisual contact will be maintained at all times with the patient.
Data collection and management: An ID number will be assigned to each separate patient, and the correlation between ID number and patient name and medical record number will be kept in a password-protected file in Dr. Amit Sawant's office. The database of information extracted from the medical record and radiation treatment records for each patient will be stored in an Excel file on a computer with password protection. All image data will be de-identified by Dr. Sawant before his research team analyzes them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung SBRT | – | –Respiratory motion causes significant geometric and dosimetric errors in the administration of lung stereotactic radiotherapy (SBRT). The purpose of this study is to create and validate patient-specific motion models of the thoracic anatomy with high spatial and temporal resolution. These models will be used to develop novel four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or metastatic lung lesions
Key inclusion criteria (8 listed)
- Eligible disease(s)/stage(s) - Patients with primary or metastatic lung lesions to be treated using stereotactic body radiotherapy (SBRT) will be eligible for this study.
- Allowable type and amount of prior therapy - Any types and amounts of prior therapy will be allowed for this study.
- Age restriction and/or gender/ethnic restrictions - Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
- Life expectancy restrictions - None.
- ECOG or Karnofsky Performance Status - Karnofsky performance status of 50 or greater
Key exclusion criteria (4 listed)
- Children (age <18)
- Women who are pregnant or trying to get pregnant
- Pain in supine position
- Karnofsky performance status < 50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who demonstrate significant motion movement during radiation therapy.
Time frame: 1.5 years
Develop novel Four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.
Results and safety
The study was stopped early (reason given: Funding for this study is over and the PI has request closure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Amit Sawant, PhD principal investigator
University of Maryland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University of Maryland, Baltimore at 2 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: Funding for this study is over and the PI has request closure.). Results are not available in the source record.
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?
Number of participants who demonstrate significant motion movement during radiation therapy. (time frame: 1.5 years). 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 8 May 2024.