Malignant Lung NeoplasmPhase 1NCT02693080
CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy
A Phase 1 study testing CAPP-Seq, Isovue-200 and Computed Tomography Perfusion Imaging in people with Malignant Lung Neoplasm and Metastatic Malignant Neoplasm in the Lung, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma
- What is being tested?
- CAPP-Seq, Isovue-200 and Computed Tomography Perfusion Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2016to 29 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
Who cannot join
- Patients who are pregnant or are trying to become pregnant are excluded from this study
- Patients with renal failure, defined as glomerular filtration rate (GFR) < 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: A Pilot Study of Perfusion CT for Lung Tumors Treated With Stereotactic Ablative Radiation Therapy (SABR)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To correlate perfusion parameters with tumor response 1 year post-SABR
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.
- Conditions
- Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma, Stage IV Lung Cancer
- Being tested
- CAPP-Seq, Isovue-200, Computed Tomography Perfusion Imaging
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPP-SeqDevice
Also called Cancer Personalized Profiling by Deep Sequencing
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.
Isovue-200Drug
Also called Lopamidol
Contrast agent
Computed Tomography Perfusion ImagingRadiation
Also called CT Perfusion Imaging
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CAPP-Seq; Drug: Isovue-200; Radiation: Computed Tomography Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning
Measured: Up to approximately 90 seconds
Number of participants able to complete perfusion scan acquisition within 48 hours of SABR
Measured: Within 48 hours post-SABR
Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR
Measured: Up to 4 months post-SABR
Secondary outcomes (4)
The calculated variance of blood flow such that measurable changes can be identified in future studies
Measured: Baseline to up to 4 months post-SABR
The calculated variance of blood volume such that measurable changes can be identified in future studies
Measured: Baseline to up to 4 months post-SABR
The calculated variance of mean transit time such that measurable changes can be identified in future studies
Measured: Baseline to up to 4 months post-SABR
The calculated variance of permeability such that measurable changes can be identified in future studies
Measured: Baseline to up to 4 months post-SABR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start19 Jan 2016
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maximilian Diehn, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693080
- Sponsor's protocol ID
- IRB-31971
- Other IDs
- NCI-2016-00091, LUN0072, IRB-31971
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2016
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Perfusion CT for Lung Tumors Treated With Stereotactic Ablative Radiation Therapy (SABR)
- ClinicalTrials.gov ID
- NCT02693080
- Acronym / sponsor ID
- IRB-31971
- Conditions
- Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma, Stage IV Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To correlate perfusion parameters with tumor response 1 year post-SABR
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CT perfusion imaging) | Experimental | Device: CAPP-Seq, Drug: Isovue-200, Radiation: Computed Tomography Perfusion ImagingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
Key exclusion criteria (2 listed)
- Patients who are pregnant or are trying to become pregnant are excluded from this study
- Patients with renal failure, defined as glomerular filtration rate (GFR) < 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPP-SeqAlso: Cancer Personalized Profiling by Deep SequencingCancer 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. | Device | Diagnostic (CT perfusion imaging) |
| Isovue-200Also: LopamidolContrast agent | Drug | Diagnostic (CT perfusion imaging) |
| Computed Tomography Perfusion ImagingAlso: CT Perfusion Imaging | Radiation | Diagnostic (CT perfusion imaging) |
Primary outcome
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning
Time frame: Up to approximately 90 seconds
Number of participants able to complete perfusion scan acquisition within 48 hours of SABR
Time frame: Within 48 hours post-SABR
Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR
Time frame: Up to 4 months post-SABR
4 secondary outcomes
The calculated variance of blood flow such that measurable changes can be identified in future studies
Time frame: Baseline to up to 4 months post-SABR
The calculated variance of blood volume such that measurable changes can be identified in future studies
Time frame: Baseline to up to 4 months post-SABR
The calculated variance of mean transit time such that measurable changes can be identified in future studies
Time frame: Baseline to up to 4 months post-SABR
The calculated variance of permeability such that measurable changes can be identified in future studies
Time frame: Baseline to up to 4 months post-SABR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian Diehn principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAPP-Seq, Isovue-200 and Computed Tomography Perfusion Imaging in people with Malignant Lung Neoplasm and Metastatic Malignant Neoplasm in the Lung, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning (time frame: Up to approximately 90 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.