Lung Cancer
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
University of Maryland, Baltimore
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years old or older * Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation | 2 years | The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dynmaic Lung MRI Lung Tumor Motion and Function | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Dynmaic Lung MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lung Tumor Motion and Lung Function | Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors | 7 participants |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lung Tumor Motion and Lung Function | Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation | 7 participants |