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).

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Ummc Msgcc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors	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.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Warren D. D'Souza, PhD, UMMC MSGCC Department of Radiation Oncology

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 19, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HP-00043875