Functional Imaging in Lung SBRT

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121300
• Other study ID #: UMCC 2015.146
• Status: Completed
• Start date: February 6, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2019
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• CT Scan
Quantitative lung SPECT-CT
• Lung CT
CT lung ventilation
• MRI
DCE MRI
• Walk Test
6 minute hall walk test
• SGRQ
St. George Respiratory Questionnaire
• Biological Sample Collection
Blood Draw
• Toxicity
Toxicity Evaluation
• Cardiac Assessment
Cardiac MRI Scan

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Cardiac Function	To explore if SBRT tumors that lie within 2 cm of the heart cause any changes in cardiac function on cardiac MRI	From baseline to 6 months post Radiation Treatment
Primary	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	Dosimetric Predictors to Assess Changes in Toxicity	To explore radiation dosimetric predictors and correlates of SPECT-CT and CT ventilation functional imaging that predict toxicity in these patients.	From baseline to 6 months post Radiation Treatment
Secondary	Changes in SPECT-CT Correlate with Changes in CT Ventilation	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).	From baseline to 6 months post Radiation Treatment
Secondary	To Assess Early Vascular Changes Using DCE-MRI	To assess early vascular changes using DCE-MRI in the lung tumor treated with SBRT as a possible predictor of tumor response.	From baseline to 6 months post Radiation Treatment