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

August 15, 2019 updated by: Department of Radiation Oncology, University of Maryland, Baltimore

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group I
This is a pilot study and there is only one group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Warren D. D'Souza, PhD, UMMC MSGCC Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP-00043875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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