NCT01421784

Brief Summary

In this study, the researchers investigate the feasibility of using rapid cine MR imaging to provide both offline and online soft-tissue-based image guidance. Such images will provide a significantly more complete picture of the spatial and temporal changes in thoracic anatomy. This more complete information will lay the groundwork for better radiotherapy planning and dose delivery in the presence of respiratory motion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2015

Completed
Last Updated

August 20, 2020

Status Verified

June 1, 2018

Enrollment Period

4.2 years

First QC Date

August 10, 2011

Last Update Submit

August 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • To measure time series of MRI imaging by the b-SSFP sequence.

    To use fast acquisition sequences to obtain 2D and 3D cine MR images of moving and deforming lung tumors. The signal to noise ration (SNR) and spatiotemporal resolution of imaging sequences will be optimized into a format potentially useful for radiotherapy guidance.

    6 weeks

Study Arms (1)

Cine-MRI

OTHER

Rapid Cine-MRI

Other: cine MRI

Interventions

Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

Cine-MRI

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AJCC Stage I, II, III or IV non-small-cell lung cancer to be treated using radiotherapy will be eligible for this study.
  • Any types and amounts of prior therapy will be allowed for this study.
  • Subjects must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Able to tolerate supine position
  • ECOG performance status of 3 or less

You may not qualify if:

  • MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
  • Women who are pregnant or trying to get pregnant
  • Pain in supine position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Amit Sawant, Ph.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 23, 2011

Study Start

September 1, 2011

Primary Completion

November 25, 2015

Study Completion

November 25, 2015

Last Updated

August 20, 2020

Record last verified: 2018-06

Locations