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

NCT01016938 | Completed Results DMC

• 1 other identifier: HP-00043875
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation

  2 years

Study Arms (1)

Group I

This is a pilot study and there is only one group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients 18 years old or older
• Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Warren D'Souza, PhD, MBA
• Organization: Universtity of Maryland School of Medicine

wdsouza@umm.edu

410-328-7159

Study Officials

• Warren D. D'Souza, PhD

  UMMC MSGCC Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 19, 2019
• Results First Posted: May 18, 2016

Record last verified: 2019-08

Locations

US (1)