Lung CancerNCT01016938
Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)
An observational study of Lung Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Who may be able to join
- Patients 18 years old or older
- Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Who cannot join
- Pregnant or breast-feeding women are excluded. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives (birthcontrol pill), intrauterine devices (IUDs), contraceptive implants under skin or contraceptive injections and condoms with foam.
- Patients with kidney disease of any severity or on hemodialysis.
- Patients who have metallic dental fillings or other metallic implants.
- Patients with known allergies to gadolinium-based contrast agents.
- Patients who have difficulty lying flat on their back for extended periods of time will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic MRI for Lung Tumor Motion and Lung Function
Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. This can damage healthy parts of the body because the exact location of the tumor is unknown.
Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of X-rays or other radiation.
Read more
The research doctors are studying to see if the position of a tumor can be tracked using MRI scans and tracking sensors placed on the skin. MRI scans and the tracking system used to calculate the location and position of the tumor are both FDA approved technologies.
The research doctors will also use the MRI scans to evaluate any changes in your lung function during and following your radiation treatments.
In this study the participant will undergo a series of MRI scans with and without contrast dye.
This study is being funded through grants from the National Institutes of Health (NIH).
Read the detailed description
In this protocol, we seek to assess whether tumor motion can be inferred using dynamic MRI and external surrogates. We propose to (1) investigate the feasibility of tracking the real-time tumor position using dynamic MRI and inferring tumor position using external surrogates placed on the skin of the subject and (2) determine lung function during and following radiation by assessing lung perfusion maps obtained via dynamic MRI with dose maps in order to determine image-based biomarkers for lung toxicity following radiation therapy.
- Conditions
- Lung Cancer
- 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 |
|---|---|---|
| Group I | This is a pilot study and there is only one group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors
Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm.
The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI.
Measured: 2 years
Secondary outcomes (1)
Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation
The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Warren D. D'Souza, PhD, Principal investigator, UMMC MSGCC Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016938
- Sponsor's protocol ID
- HP-00043875
- Status last verified
- Aug 2019
- First submitted
- 19 Nov 2009
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic MRI for Lung Tumor Motion and Lung Function
- ClinicalTrials.gov ID
- NCT01016938
- Acronym / sponsor ID
- HP-00043875
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Nov 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 18 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. This can damage healthy parts of the body because the exact location of the tumor is unknown.
Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of X-rays or other radiation.
The research doctors are studying to see if the position of a tumor can be tracked using MRI scans and tracking sensors placed on the skin. MRI scans and the tracking system used to calculate the location and position of the tumor are both FDA approved technologies.
The research doctors will also use the MRI scans to evaluate any changes in your lung function during and following your radiation treatments.
In this study the participant will undergo a series of MRI scans with and without contrast dye.
This study is being funded through grants from the National Institutes of Health (NIH).
Detailed description
In this protocol, we seek to assess whether tumor motion can be inferred using dynamic MRI and external surrogates. We propose to (1) investigate the feasibility of tracking the real-time tumor position using dynamic MRI and inferring tumor position using external surrogates placed on the skin of the subject and (2) determine lung function during and following radiation by assessing lung perfusion maps obtained via dynamic MRI with dose maps in order to determine image-based biomarkers for lung toxicity following radiation therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –This is a pilot study and there is only one group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Key inclusion criteria (2 listed)
- Patients 18 years old or older
- Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women are excluded. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives (birthcontrol pill), intrauterine devices (IUDs), contraceptive implants under skin or contraceptive injections and condoms with foam.
- Patients with kidney disease of any severity or on hemodialysis.
- Patients who have metallic dental fillings or other metallic implants.
- Patients with known allergies to gadolinium-based contrast agents.
- Patients who have difficulty lying flat on their back for extended periods of time will be excluded
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 Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors
Time frame: 2 years
Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI.
1 secondary outcome
Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Warren D. D'Souza, PhD principal investigator
UMMC MSGCC Department of Radiation Oncology
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 Lung Cancer, run by University of Maryland, Baltimore 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 5 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 19 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors (time frame: 2 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 19 Aug 2019.