Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00091 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| LUN0072 | Other Identifier | OnCore | |
| IRB-31971 | Other Identifier | Stanford IRB |
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
This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.
PRIMARY OBJECTIVES:
I. To assess the feasibility of performing computed tomography (CT) perfusion imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care.
SECONDARY OBJECTIVES:
OUTLINE:
Patients receive an infusion of Isovue-200 and undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) will be conducted evaluate circulating-tumor DNA levels.
Perfusion parameters will be correlated with tumor control at 1 year post-SABR, with tumor control defined as no evidence of disease seen at the site of SABR by surveillance imaging at 1 year post-SABR.
After completion of treatment, patients are followed up at 2-4 months and then at 1 year.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CT perfusion imaging) | Experimental | Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPP-Seq | Device | Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) is an assay which allows quantitative assessment of the levels of circulating-tumor DNA in the blood sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants able to complete perfusion scan acquisition at the time of treatment-planning | Up to approximately 90 seconds | |
| Number of participants able to complete perfusion scan acquisition within 48 hours of SABR | Within 48 hours post-SABR | |
| Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR | Up to 4 months post-SABR |
| Measure | Description | Time Frame |
|---|---|---|
| The calculated variance of blood flow such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR | |
| The calculated variance of blood volume such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maximilian Diehn | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2020 | May 31, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Isovue-200 | Drug | Contrast agent |
|
|
| Computed Tomography Perfusion Imaging | Radiation |
|
|
| The calculated variance of mean transit time such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
| The calculated variance of permeability such that measurable changes can be identified in future studies | Baseline to up to 4 months post-SABR |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007479 | Iopamidol |
| D007483 | Iothalamic Acid |
| D003570 | Cytidine Triphosphate |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided