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Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)

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ClinicalTrials.gov Identifier: NCT01016938
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : May 18, 2016
Last Update Posted : May 18, 2016
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland

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).

Condition or disease
Lung Cancer

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 Type : Observational
Actual Enrollment : 16 participants
Time Perspective: Prospective
Official Title: Dynamic MRI for Lung Tumor Motion and Lung Function
Study Start Date : November 2009
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group I
This is a pilot study and there is only one group.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation [ Time Frame: 2 years ]
    The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016938

United States, Maryland
Ummc Msgcc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
National Institutes of Health (NIH)
Principal Investigator: Warren D. D'Souza, PhD UMMC MSGCC Department of Radiation Oncology

Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01016938     History of Changes
Other Study ID Numbers: HP-00043875
First Posted: November 20, 2009    Key Record Dates
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016
Last Verified: April 2016