Functional Imaging in Lung SBRT
Functional Outcomes for Stereotactic Body Radiotherapy of Lung Lesions in High Risk Patients
1 other identifier
observational
33
1 country
1
Brief Summary
Little is known about the safety of body radiation therapy (SBRT), especially the impact on pulmonary function, quality of life, and on functional changes within the lung itself. Radiation dose constraints and capturing functional changes on imaging are not well studied in this setting. The current study aims to evaluate the utility of advanced imaging to measure lung function prior to and after treatment and to assess the feasibility of using this data to adapt SBRT planning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2017
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedOctober 17, 2019
October 1, 2019
2.6 years
April 14, 2017
October 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Longitudinal Changes in Lung Function
To characterize longitudinal changes in lung function using SPECT/CT and CT ventilation scans in "high risk" patients undergoing standard SBRT treatments.
From baseline to 6 months post Radiation Treatment
Secondary Outcomes (3)
Dosimetric Predictors to Assess Changes in Toxicity
From baseline to 6 months post Radiation Treatment
Changes in SPECT-CT Correlate with Changes in CT Ventilation
From baseline to 6 months post Radiation Treatment
To Assess Early Vascular Changes Using DCE-MRI
From baseline to 6 months post Radiation Treatment
Other Outcomes (1)
Changes in Cardiac Function
From baseline to 6 months post Radiation Treatment
Study Arms (1)
High Risk Lung Cancer Patients
Interventions
Eligibility Criteria
High Risk Lung Cancer Patients
You may qualify if:
- Patients receiving SBRT lung treatment and who have any one of the following high risk features:
- Lung lesion \> 5 cm
- DLCO \< 35%
- FEV1 \< 0.5 L
- Central lung tumors (defined as within 2 cm from the proximal bronchial tree)
- Tumors that abut the great vessels, trachea, spinal cord, or esophagus
- Prior lobectomy or pneumonectomy
- Prior lung radiation (SBRT or conventional definitive lung radiation)
- Patients must be 18 years of age or older
You may not qualify if:
- Patients who have received targeted agents or systemic potentially radiosensitizing chemotherapy within 2 weeks of lung SBRT start
- Pregnancy or lactation
- Unable to tolerate MRI without anesthesia
- Inability cooperate with the scans
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Biospecimen
Patients will have 20 mL of blood collected by venipuncture at the specified time points.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shruti Jolly, M.D.
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 20, 2017
Study Start
February 6, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
October 17, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share