Primary Liver CancerNCT02722395
Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)
An observational study of Primary Liver Cancer and Metastatic Liver Cancer From Any Cancer Site, run by Duke University at 1 site in United States.
Trial summary
This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Liver Cancer, Metastatic Liver Cancer From Any Cancer Site
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 1 Feb 2017
- 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: Patients with stage I, II, III primary liver cancer Patients with metastatic liver cancer from any cancer site
Who may be able to join
- Age ≥ 21
- Patients with primary stage I, II, III liver cancer or metastatic tumor in the liver from any cancer site
- Signed, specific informed consent prior to study entry
- Women of child bearing potential must have a negative serum pregnancy test
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.
- Pregnant or breast-feeding women are excluded.
- 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
This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT).
Read the detailed description
There is a potential role to systematically implement MRI to establish appropriate workflow of the implementation for tumor motion management in liver SBRT. Compared to CT, MRI has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. MRI solely based liver SBRT will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| Single arm cohort study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure average motion trajectories
Measured: During MRI approx 1 hour
Image quality, as measured by image rating
Image quality will be measured on a scale of 1 to 5, 1 being the best.
Measured: During MRI approx 1 hour
Image quality, as measured by tumor volume
Measured: During MRI approx 1 hour
Image quality, as measured by tumor-to-live contrast to noise ratio
Measured: During MRI approx 1 hour
Planning target volume (PTV)
PTV is defined as PTV=internal target volume (ITV) + safety margin (M)
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 posted30 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Czito, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722395
- Sponsor's protocol ID
- Pro00071159
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)
- ClinicalTrials.gov ID
- NCT02722395
- Acronym / sponsor ID
- Pro00071159
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 30 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.
This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT).
Detailed description
There is a potential role to systematically implement MRI to establish appropriate workflow of the implementation for tumor motion management in liver SBRT. Compared to CT, MRI has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. MRI solely based liver SBRT will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm cohort study | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I, II, III primary liver cancer Patients with metastatic liver cancer from any cancer site
Key inclusion criteria (4 listed)
- Age ≥ 21
- Patients with primary stage I, II, III liver cancer or metastatic tumor in the liver from any cancer site
- Signed, specific informed consent prior to study entry
- Women of child bearing potential must have a negative serum pregnancy test
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.
- Pregnant or breast-feeding women are excluded.
- 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
Measure average motion trajectories
Time frame: During MRI approx 1 hour
Image quality, as measured by image rating
Time frame: During MRI approx 1 hour
Image quality will be measured on a scale of 1 to 5, 1 being the best.
Image quality, as measured by tumor volume
Time frame: During MRI approx 1 hour
Image quality, as measured by tumor-to-live contrast to noise ratio
Time frame: During MRI approx 1 hour
Planning target volume (PTV)
Time frame: During MRI approx 1 hour
PTV is defined as PTV=internal target volume (ITV) + safety margin (M)
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 6 Apr 2017.
- 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.
Brian Czito 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 Primary Liver Cancer and Metastatic Liver Cancer From Any Cancer Site, 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 6 Apr 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?
Measure average motion trajectories (time frame: During MRI approx 1 hour). The study lists 5 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 6 Apr 2017.