Skip to main content
OpenTrials
Completed

NCT Number: NCT03121300

Functional Imaging in Lung SBRT

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

Stereotactic body radiation therapy (SBRT) is becoming a new standard for unresectable lung metastases and primary lung cancers.

However, it is becoming increasingly common for patients to undergo multiple courses of lung SBRT to synchronous and/or metachronous lung lesions. Further, the indications for SBRT are being expanded to patients who have very poor pulmonary function such as FEV1 < 0.5 L or DLCO < 35% predicted, who have large tumors (>3 cm), or who have centrally located lesions that abut great vessels and mainstem bronchi. Little is known about the safety of such treatments, 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. SPECT/CT will be used to measure ventilation and perfusion changes while. CT ventilation scans will be used to correlate functional changes observed on diagnostic SPECT/CT. Dynamic contrast enhanced MRI (DCE-MRI) will also be used to explore local vascular changes in the treated tumor. In patients whose tumors lie close to the heart, cardiac MRI will be used to investigate whether high doses of radiation per fraction are associated with changes in cardiac function. These imaging modalities may be used to potentially predict toxicity and patient response with the ultimate goal of prospectively adapt dose to individual patient and tumor characteristics. Lung function prior to and post-treatment will also be measured as a correlate of functional imaging changes. Identifying areas of the lung that are sub-functional or low-functioning may offer an opportunity to adapt stereotactic ablations that spare functional lung thereby making SBRT treatments to higher risk patients safer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CT scan

Other

Quantitative lung SPECT-CT

Lung CT

Other

CT lung ventilation

MRI

Other

DCE MRI

Walk Test

Other

6 minute hall walk test

SGRQ

Other

St. George Respiratory Questionnaire

Biological sample collection

Other

Blood Draw

Toxicity

Other

Toxicity Evaluation

Cardiac Assessment

Other

Cardiac MRI Scan

Primary outcomes

  1. Longitudinal Changes in Lung Function

    Time frame: From baseline to 6 months post Radiation Treatment

    To characterize longitudinal changes in lung function using SPECT/CT and CT ventilation scans in "high risk" patients undergoing standard SBRT treatments.

Secondary outcomes

  1. Dosimetric Predictors to Assess Changes in Toxicity

    Time frame: From baseline to 6 months post Radiation Treatment

    To explore radiation dosimetric predictors and correlates of SPECT-CT and CT ventilation functional imaging that predict toxicity in these patients.

  2. Changes in SPECT-CT Correlate with Changes in CT Ventilation

    Time frame: From baseline to 6 months post Radiation Treatment

    To determine if early functional changes in SPECT-CT correlate with changes in CT ventilation, pulmonary function and patient reported decrements in lung function on the St. George Respiratory Questionnaire (SGRQ).

  3. To Assess Early Vascular Changes Using DCE-MRI

    Time frame: From baseline to 6 months post Radiation Treatment

    To assess early vascular changes using DCE-MRI in the lung tumor treated with SBRT as a possible predictor of tumor response.

Other outcomes

  1. Changes in Cardiac Function

    Time frame: From baseline to 6 months post Radiation Treatment

    To explore if SBRT tumors that lie within 2 cm of the heart cause any changes in cardiac function on cardiac MRI

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Functional Outcomes for Stereotactic Body Radiotherapy of Lung Lesions in High Risk Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2017
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.