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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier:
NCT01016938
First received: November 19, 2009
Last updated: April 22, 2014
Last verified: April 2014
  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 University of Maryland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016938

Contacts
Contact: Bahiyyah K Jackson, MS 410-328-7586 bjackson1@umm.edu
Contact: Suzanne M. Grim, MS 410-328-7501 sgrim@umm.edu

Locations
United States, Maryland
Ummc Msgcc Recruiting
Baltimore, Maryland, United States, 21201
Contact: Suzanne M. Grim, MS    410-328-7501    sgrim@umm.edu   
Principal Investigator: Warren D. D'Souza, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Warren D. D'Souza, PhD UMMC MSGCC Department of Radiation Oncology
  More Information

No publications provided

Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01016938     History of Changes
Other Study ID Numbers: HP-00043875
Study First Received: November 19, 2009
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014