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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier:
NCT01016938
First received: November 19, 2009
Last updated: April 11, 2016
Last verified: April 2016

November 19, 2009
April 11, 2016
November 2009
October 2015   (final data collection date for primary outcome measure)
Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

To assess whether dynamic MRI without contrast and external surrogates can be used to determine real-time lung tumor position. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01016938 on ClinicalTrials.gov Archive Site
Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.
To assess whether lung perfusion after radiation therapy measured using dynamic MRI with contrast can be associated with radiation dose. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)
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.

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).

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.
Observational
Time Perspective: Prospective
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Non-Probability Sample
Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
Lung Cancer
Not Provided
Group I
This is a pilot study and there is only one group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016938
HP-00043875
Yes
Not Provided
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Department of Radiation Oncology, University of Maryland
University of Maryland
National Institutes of Health (NIH)
Principal Investigator: Warren D. D'Souza, PhD UMMC MSGCC Department of Radiation Oncology
University of Maryland
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP