Functional Imaging in Lung SBRT

Completed

• Conditions: Lung Cancer
• Interventions: Other: CT Scan; Other: Lung CT; Other: MRI; Other: Walk Test; Other: SGRQ; Other: Biological Sample Collection; Other: Toxicity; Other: Cardiac Assessment

• Registration Number: NCT03121300
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Study Timeline

• Study Start: 2017-02-06
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-20
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Risk Lung Cancer Patients	Toxicity	-
High Risk Lung Cancer Patients	MRI	-
High Risk Lung Cancer Patients	CT Scan	-
High Risk Lung Cancer Patients	Cardiac Assessment	-
High Risk Lung Cancer Patients	Walk Test	-
High Risk Lung Cancer Patients	Biological Sample Collection	-
High Risk Lung Cancer Patients	Lung CT	-
High Risk Lung Cancer Patients	SGRQ	-

Primary Outcome Measures

Name	Time	Method
Longitudinal Changes in Lung Function	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 Outcome Measures

Name	Time	Method
To Assess Early Vascular Changes Using DCE-MRI	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.
Dosimetric Predictors to Assess Changes in Toxicity	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.
Changes in SPECT-CT Correlate with Changes in CT Ventilation	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).

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States