Clinical trial NCT01016938: Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)
Official title: Dynamic MRI for Lung Tumor Motion and Lung Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-11-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Ummc Msgcc
state: Maryland
Study officials:
affiliation: UMMC MSGCC Department of Radiation Oncology
name: Warren D. D'Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References: