Liver Cancer, Lung Cancer, Pancreatic CancerNCT02019199
Magnetic Resonance Imaging (MRI) in Motion
An observational study of Liver Cancer, Lung Cancer, Pancreatic Cancer, run by Duke University at 1 site in United States.
Trial summary
This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Liver Cancer, Lung Cancer, Pancreatic Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults males or females with primary or secondary cancer tumors of the lung, liver or pancreas
Who may be able to join
- Age ≥ 21
- Patients with primary or metastatic tumors in the lungs, liver, or pancreas
- Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4D-CT ordered by the treating Radiation Oncologist
- Signed, specific informed consent prior to study entry
Who cannot join
- Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc
- Pregnant or breast-feeding women
- Subjects who have difficulty lying flat on their back for extended periods of time
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Magnetic Resonance Imaging ( MRI) for Radiation Therapy Treatment Planning Evaluation of Lung, Liver and Pancreatic Motion.
This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.
Read the detailed description
The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.
- Medical subject headings
- Liver Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.
MRI and CT ( all subjects will have a standard of care CT scan) data in DICOM format will be collected for analysis using commercial or customized - developed software. Image quality will be assessed based on signal-to-noise (SNR), contrast-to-noise ratio (CNR), and the presence of image artifacts. Data to be computed include, but are not limited to, tumor volumes (gross tumor volume, internal target volume, planning target volume, etc.), tumor motion parameters (range, trajectory, frequency, variation, probability distribution, etc.), and treatment plan parameters (target coverage, dose-volume-histogram, etc.).
Measured: During MRI approx 1 hour
Tumor volume
Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT
Measured: During MRI approx 1 hour
Tumor contrast-to-noise ratio (CNR)
Difference between CNR is measured by 4D-MRI and 4D-CT
Measured: During MRI approx 1 hour
Tumor Motion
Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT
Measured: During MRI approx 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startNov 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, Lung Cancer, Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Czito, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019199
- Sponsor's protocol ID
- Pro00032595
- Status last verified
- Jul 2017
- First submitted
- 18 Dec 2013
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging ( MRI) for Radiation Therapy Treatment Planning Evaluation of Lung, Liver and Pancreatic Motion.
- ClinicalTrials.gov ID
- NCT02019199
- Acronym / sponsor ID
- Pro00032595
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Dec 2013 (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.
This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.
Detailed description
The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults males or females with primary or secondary cancer tumors of the lung, liver or pancreas
Key inclusion criteria (4 listed)
- Age ≥ 21
- Patients with primary or metastatic tumors in the lungs, liver, or pancreas
- Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4D-CT ordered by the treating Radiation Oncologist
- Signed, specific informed consent prior to study entry
Key exclusion criteria (3 listed)
- Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc
- Pregnant or breast-feeding women
- Subjects who have difficulty lying flat on their back for extended periods of time
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
To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement.
Time frame: During MRI approx 1 hour
MRI and CT ( all subjects will have a standard of care CT scan) data in DICOM format will be collected for analysis using commercial or customized - developed software. Image quality will be assessed based on signal-to-noise (SNR), contrast-to-noise ratio (CNR), and the presence of image artifacts. Data to be computed include, but are not limited to, tumor volumes (gross tumor volume, internal target volume, planning target volume, etc.), tumor motion parameters (range, trajectory, frequency, variation, probability distribution, etc.), and treatment plan parameters (target coverage, dose-volume-histogram, etc.).
Tumor volume
Time frame: During MRI approx 1 hour
Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT
Tumor contrast-to-noise ratio (CNR)
Time frame: During MRI approx 1 hour
Difference between CNR is measured by 4D-MRI and 4D-CT
Tumor Motion
Time frame: During MRI approx 1 hour
Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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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.
Brian Czito, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, Lung Cancer, Pancreatic Cancer, run by Duke University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jul 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement. (time frame: During MRI approx 1 hour). The study lists 4 primary outcomes in all. 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 11 Jul 2017.