Breast CancerNCT03524248
Development of Real-time Image-guided Radiotherapy
A study testing Image guided radiation therapy in people with Breast Cancer and Lung Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Skin Cancer
- What is being tested?
- Image guided radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2012to 19 Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- All patients benefit from advanced IGRT can participate to the study except for those emergent and pediatric patients (age <18 years) who require special care or there is no time for the setup the 4D video systems
- The patient population would be selected according to the technical progress and clinical needs
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup or motion errors can be detected and corrected. However, CBCT is not available for situations with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any irregular respiration or body movement during beam-on time. Thus, it is essential to develop a real-time image system that can detect organ/body motion during beam-on time, and correlate simulation-planning images with prior treatment CBCT images.In this proposed clinical trial, we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging techniques and validate the feasibility and accuracy of 4D video image guidance in correlation with 4D CT/CBCT useful for advanced IGRT.
- Conditions
- Breast Cancer, Lung Cancer, Skin Cancer
- Being tested
- Image guided radiation therapy
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image guided radiation therapyRadiation
Real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT).
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT).
Real time 4-D video imaging in combination with CBCT to detect appropriate delivery of radiotherapy
Measured: 12 years
Secondary outcomes (1)
To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images
Align 4D surface images with internal structures
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start17 May 2012
- Primary completion16 Jul 2018
- Study completion19 Jul 2018
Why it stopped: Camera for study is being repaired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524248
- Sponsor's protocol ID
- 16-6006
- Status last verified
- Feb 2020
- First submitted
- 2 May 2018
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Real-time Image-guided Radiotherapy
- ClinicalTrials.gov ID
- NCT03524248
- Acronym / sponsor ID
- 16-6006
- Conditions
- Breast Cancer, Lung Cancer, Skin Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Camera for study is being repaired
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 17 May 2012 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 14 May 2018 (actual)
- 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 goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup or motion errors can be detected and corrected. However, CBCT is not available for situations with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any irregular respiration or body movement during beam-on time. Thus, it is essential to develop a real-time image system that can detect organ/body motion during beam-on time, and correlate simulation-planning images with prior treatment CBCT images.In this proposed clinical trial, we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging techniques and validate the feasibility and accuracy of 4D video image guidance in correlation with 4D CT/CBCT useful for advanced IGRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients benefit from advanced IGRT can participate to the study except for those emergent and pediatric patients (age <18 years) who require special care or there is no time for the setup the 4D video systems
- The patient population would be selected according to the technical progress and clinical needs
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Image guided radiation therapyReal-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT). | Radiation | – |
Primary outcome
Develop real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT).
Time frame: 12 years
Real time 4-D video imaging in combination with CBCT to detect appropriate delivery of radiotherapy
1 secondary outcome
To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images
Time frame: 12 years
Results and safety
The study was stopped early (reason given: Camera for study is being repaired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided radiation therapy in people with Breast Cancer and Lung Cancer, run by Fox Chase Cancer Center at 1 site 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 2 inclusion and 1 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Camera for study is being repaired). 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?
Develop real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT). (time frame: 12 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 2 Mar 2020.