Functional Imaging in Lung SBRT

NCT ID: NCT03121300

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2019-08-30

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.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

High Risk Lung Cancer Patients

CT Scan

Intervention Type: OTHER

Quantitative lung SPECT-CT

Lung CT

Intervention Type: OTHER

CT lung ventilation

MRI

Intervention Type: OTHER

DCE MRI

Walk Test

Intervention Type: OTHER

6 minute hall walk test

SGRQ

Intervention Type: OTHER

St. George Respiratory Questionnaire

Biological Sample Collection

Intervention Type: OTHER

Blood Draw

Toxicity

Intervention Type: OTHER

Toxicity Evaluation

Cardiac Assessment

Intervention Type: OTHER

Cardiac MRI Scan

Interventions

CT Scan

Quantitative lung SPECT-CT

Intervention Type: OTHER

Lung CT

CT lung ventilation

Intervention Type: OTHER

MRI

DCE MRI

Intervention Type: OTHER

Walk Test

6 minute hall walk test

Intervention Type: OTHER

SGRQ

St. George Respiratory Questionnaire

Intervention Type: OTHER

Biological Sample Collection

Blood Draw

Intervention Type: OTHER

Toxicity

Toxicity Evaluation

Intervention Type: OTHER

Cardiac Assessment

Cardiac MRI Scan

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shruti Jolly, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 2015.146

Identifier Type: -

Identifier Source: org_study_id