Pancreatic CancerNCT01071434
Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors
An observational study of Pancreatic Cancer and Liver Cancer, run by Stanford University at 1 site in United States.
Trial summary
This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Liver Cancer, Lung Cancer
- What is being tested?
- MR Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2010
- 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: Eligible disease(s)/stage(s) \\AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.
Inclusion Criteria:3.1.1. Eligible disease(s)/stage(s) \\AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.
3.1.2. Allowable type and amount of prior therapy \ Any types and amounts of prior therapy will be allowed for this study.
3.1.3. 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.
3.1.4. Life expectancy restrictions \ None.
3.1.5. ECOG or Karnofsky Performance Status \ Karnofsky performance status of 50 or greater
3.1.6. Requirements for organ and marrow function \ None.
3.1.7. Ability to understand and the willingness to sign a written informed consent document.
3.1.8. Pain-free in supine position Exclusion Criteria:3.2.1 Children (age <18)
3.2.2 Metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
3.2.3 Women who are pregnant or trying to get pregnant
3.2.4 Pain in supine position
3.2.5 Karnofsky performance status < 50
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors
This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.
Read the detailed description
Accurate dose delivery remains one of the weakest aspects of radiotherapy, especially in the case of thoracic and abdominal tumors, where significant patient motion occurs during dose delivery (intrafraction motion). Such motion results in geometric and dosimetric uncertainties that compromise treatment quality. Effective management of intrafraction motion is therefore key to realizing the full potential of modern image-guided radiation therapy (IGRT). While external markers have been found to be well-correlated with internal anatomy within an imaging session, there is no guarantee that these correlations will continue to exist and be constant throughout the course of the therapy. In general, implanted, radio-opaque seeds have been found to be more reliable than external markers. However, implantation of fiducials, whether radio-opaque or electromagnetic, is necessarily invasive and carries with it the risk of associated complications - an issue that becomes especially important for cancer patients with weakened immune systems. Currently, MR imaging is the only modality that is non-invasive and provides high quality volumetric information for the whole body.
The "ideal" intrafraction motion management requires complete spatio-temporal knowledge of the irradiated anatomy. However, to date, there is no clinical method of directly visualizing the tumor volume during dose delivery. Most techniques rely on external or internal surrogate markers which often provide (usually non-volumetric) information of limited accuracy and reliability. In addition, internal markers impose significant "costs" on the patient in terms of interventional complications and increased imaging dose. In this work, we investigate the feasibility of using in-room, fast cine MR imaging as a non-invasive means to provide real-time, soft-tissue-based, volumetric image guidance for continuous monitoring of the target and surrounding anatomy. To date, there has been no systematic investigation of the imaging requirements of an integrated MRI+linac for the specific task of real-time radiotherapy guidance.
- Conditions
- Pancreatic Cancer, Liver Cancer, Lung Cancer, Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Hepatobiliary Cancers
- Being tested
- MR Imaging
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR ImagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The American Association of Physicists in Medicine
- Responsible party
- Sponsor
- Investigators
- Amit Sawant, Principal investigator, Stanford UniversityPaul J Keall, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071434
- Sponsor's protocol ID
- VAR0042
- Other IDs
- SU-06112009-2702
- Status last verified
- Dec 2012
- First submitted
- 16 Dec 2009
- Last updated
- 7 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors
- ClinicalTrials.gov ID
- NCT01071434
- Acronym / sponsor ID
- VAR0042
- Conditions
- Pancreatic Cancer, Liver Cancer, Lung Cancer, Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Hepatobiliary Cancers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The American Association of Physicists in Medicine
- Study start
- Feb 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Feb 2010 (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 aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.
Detailed description
Accurate dose delivery remains one of the weakest aspects of radiotherapy, especially in the case of thoracic and abdominal tumors, where significant patient motion occurs during dose delivery (intrafraction motion). Such motion results in geometric and dosimetric uncertainties that compromise treatment quality. Effective management of intrafraction motion is therefore key to realizing the full potential of modern image-guided radiation therapy (IGRT). While external markers have been found to be well-correlated with internal anatomy within an imaging session, there is no guarantee that these correlations will continue to exist and be constant throughout the course of the therapy. In general, implanted, radio-opaque seeds have been found to be more reliable than external markers. However, implantation of fiducials, whether radio-opaque or electromagnetic, is necessarily invasive and carries with it the risk of associated complications - an issue that becomes especially important for cancer patients with weakened immune systems. Currently, MR imaging is the only modality that is non-invasive and provides high quality volumetric information for the whole body.
The "ideal" intrafraction motion management requires complete spatio-temporal knowledge of the irradiated anatomy. However, to date, there is no clinical method of directly visualizing the tumor volume during dose delivery. Most techniques rely on external or internal surrogate markers which often provide (usually non-volumetric) information of limited accuracy and reliability. In addition, internal markers impose significant "costs" on the patient in terms of interventional complications and increased imaging dose. In this work, we investigate the feasibility of using in-room, fast cine MR imaging as a non-invasive means to provide real-time, soft-tissue-based, volumetric image guidance for continuous monitoring of the target and surrounding anatomy. To date, there has been no systematic investigation of the imaging requirements of an integrated MRI+linac for the specific task of real-time radiotherapy guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible disease(s)/stage(s) \\AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.
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 |
|---|---|---|
| MR Imaging | Procedure or surgery | – |
Primary outcome
investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.
Time frame: two hours
Results and safety
The study was stopped early (reason given: PI left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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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 principal investigator
Stanford University
Paul J Keall principal investigator
Stanford 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 Pancreatic Cancer and Liver Cancer, run by Stanford 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?
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 7 Dec 2012. 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: PI left). 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?
investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors. (time frame: two hours). 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 7 Dec 2012.