Lung CancerNCT03121300
Functional Imaging in Lung SBRT
An observational study of Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT Scan, Lung CT and MRI
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 30 Aug 2019
- Phase
- Observational
- 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
Study population: High Risk Lung Cancer Patients
Who may be able to join
- 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
Show all 9Show fewer
- Prior lobectomy or pneumonectomy
- Prior lung radiation (SBRT or conventional definitive lung radiation)
- Patients must be 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcomes for Stereotactic Body Radiotherapy of Lung Lesions in High Risk Patients
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- CT Scan, Lung CT, MRI, Walk Test, SGRQ
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanOther
Quantitative lung SPECT-CT
Lung CTOther
CT lung ventilation
MRIOther
DCE MRI
Walk TestOther
6 minute hall walk test
SGRQOther
St. George Respiratory Questionnaire
Biological Sample CollectionOther
Blood Draw
ToxicityOther
Toxicity Evaluation
Cardiac AssessmentOther
Cardiac MRI Scan
| Study group | Role | What they receive |
|---|---|---|
| High Risk Lung Cancer Patients | Not described Receives: Other: CT Scan; Other: Lung CT; Other: MRI; Other: Walk Test; Other: SGRQ; Other: Biological Sample Collection; Other: Toxicity; Other: Cardiac Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months post Radiation Treatment
Secondary outcomes (3)
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.
Measured: From baseline to 6 months post Radiation Treatment
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).
Measured: 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.
Measured: From baseline to 6 months post Radiation Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start6 Feb 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Shruti Jolly, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121300
- Sponsor's protocol ID
- UMCC 2015.146
- Status last verified
- Oct 2019
- First submitted
- 14 Apr 2017
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes for Stereotactic Body Radiotherapy of Lung Lesions in High Risk Patients
- ClinicalTrials.gov ID
- NCT03121300
- Acronym / sponsor ID
- UMCC 2015.146
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk Lung Cancer Patients | – | Other: CT Scan, Other: Lung CT, Other: MRI, Other: Walk Test, Other: SGRQ, Other: Biological Sample Collection, Other: Toxicity, Other: Cardiac Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High Risk Lung Cancer Patients
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CT ScanQuantitative lung SPECT-CT | Other | High Risk Lung Cancer Patients |
| Lung CTCT lung ventilation | Other | High Risk Lung Cancer Patients |
| MRIDCE MRI | Other | High Risk Lung Cancer Patients |
| Walk Test6 minute hall walk test | Other | High Risk Lung Cancer Patients |
| SGRQSt. George Respiratory Questionnaire | Other | High Risk Lung Cancer Patients |
| Biological Sample CollectionBlood Draw | Other | High Risk Lung Cancer Patients |
| ToxicityToxicity Evaluation | Other | High Risk Lung Cancer Patients |
| Cardiac AssessmentCardiac MRI Scan | Other | High Risk Lung Cancer Patients |
Primary outcome
Longitudinal Changes in Lung Function
Time frame: 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.
3 secondary outcomes
Dosimetric Predictors to Assess Changes in Toxicity
Time frame: From baseline to 6 months post Radiation Treatment
Changes in SPECT-CT Correlate with Changes in CT Ventilation
Time frame: From baseline to 6 months post Radiation Treatment
To Assess Early Vascular Changes Using DCE-MRI
Time frame: From baseline to 6 months post Radiation Treatment
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 17 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Shruti Jolly, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University of Michigan Rogel Cancer Center 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 9 inclusion and 4 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 17 Oct 2019. 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.
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?
Longitudinal Changes in Lung Function (time frame: From baseline to 6 months post Radiation Treatment). 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 17 Oct 2019.