Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk Lung Cancer Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Scan | Other | Quantitative lung SPECT-CT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in SPECT-CT Correlate with Changes in CT Ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
High Risk Lung Cancer Patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shruti Jolly, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will have 20 mL of blood collected by venipuncture at the specified time points.
| 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 |
|
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 |
| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |