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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016938
First Posted: November 20, 2009
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
  Purpose

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
Lung Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Dynamic MRI for Lung Tumor Motion and Lung Function

Resource links provided by NLM:


Further study details as provided by Department of Radiation Oncology, University of Maryland:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 16
Study Start Date: November 2009
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group I
This is a pilot study and there is only one group.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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
  Contacts and Locations
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


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

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 Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: December 2, 2015
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016
Last Verified: April 2016