Lung CancerNCT04060927
Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung
A study testing SGRT in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. 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?
- SGRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to Oct 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent with HIPAA authorization for release of personal health information.
- Age ≥18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of fiducials in combination with SBRT in subjects <18 years of age, children are excluded from this study.
- ECOG Performance Status of ≤ 2.
- Stage IA-IIB (T1a-T3bN0) presumed non-small cell lung cancer, carcinoid tumors, or lung metastasis that have ≥ 1 cm of respiratory associated motion measured on 4DCT at time of simulation for SBRT with or without respiratory motion suppression techniques. Histologic confirmation of malignancy is encouraged but not required. Primary or metastatic tumor ≤ 7 cm.
- Subjects may be receiving systemic chemotherapy or other systemic agents prior to enrollment, but these agents must be stopped during SBRT treatments.
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- Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 14 days prior to day 1 of treatment. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
- The effects of radiation on the developing human fetus are not well described. For this reason, women of child-bearing potential and non-sterilized men who are sexually active with a woman of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of <1% per year when used consistently and correctly) from the time of informed consent until 5 days after last dose of SBRT. Contraceptive methods with low user dependency are preferable but not required.
- As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Prior radiation to the chest that would overlap with the current radiation fields and determined by the treating physician to impede the treatment of the study malignancy.
- Active ongoing pulmonary infection or pneumonitis that is requiring active treatment with antibiotics or steroids. Prior pneumonitis from drug or other therapies that has been treated within 15 days of first day of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: LCI-LUN-SBRT-002: Pilot Study of SGRT Alone vs. SGRT in Combination With Fiducials for Breath Hold SBRT Treatments of the Lung
This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.
Read the detailed description
The study's primary objective is estimate the incidence of SBRT and fiducial-related pulmonary toxicities for subjects treated with SBRT who have tumors that move ≥ 1 cm in 3 different cohorts: 1) free breathing with SGRT 2) breath hold utilizing SGRT only; 3) breath hold utilizing SGRT in combination with implanted fiducials. Secondary objectives also include Estimate reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials estimating local control for SBRT in subjects treated in the three different cohorts, estimating overall survival, and evaluating quality of life. A safety objective of estimating acute and long-term grade 2 or higher non-hematologic toxicities attributed to SBRT/fiducial implantation in subjects treated in the three different cohorts will also be explored.
- Conditions
- Lung Cancer
- Being tested
- SGRT
- Keywords
- NSCLC, Lung, Radiation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGRTDevice
Surface Guided Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Freebreathing SBRT with SGRT Receives: Device: SGRT |
| Group 2 | Experimental | Breath hold SBRT with SGRT Receives: Device: SGRT |
| Group 3 | Experimental | Breath hold SBRT with SGRT in combination with implanted fiducials Receives: Device: SGRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 2 or Higher SBRT-related Pulmonary Toxicities as Assessed by NCI CTCAE v.5.0
A binary variable was determined for each participant indicating whether the participant experienced at least one grade 2 or higher pulmonary adverse event (according to NCI Common Terminology for Adverse Events version 5.0) during treatment or within 12 months after completion of SBRT that was determined to be related (possibly, probably, or definitely attributed) to SBRT.
Measured: from date of SBRT start or fiducial placement to 12 months after completion of SBRT treatment
Number of Participants With Grade 2 or Higher Fiducial-related Pulmonary Toxicities as Assessed by NCI CTCAE v.5.0
A binary variable was determined for each participant indicating whether the participant experienced at least one grade 2 or higher pulmonary adverse event (according to NCI Common Terminology for Adverse Events version 5.0) during treatment or within 12 months after completion of SBRT that was determined to be related (possibly, probably, or definitely attributed) to implantation of fiducials.
Measured: from date of fiducial placement to 12 months after completion of SBRT treatment
Secondary outcomes (5)
Reliability of Gated SBRT Treatments Utilizing SGRT vs. SGRT With Fiducials - Directional Shifts
Measured shift deltas for each of the directional (in cm; vertical, longitudinal, lateral) shifts were determined utilizing surface guided radiation therapy (SGRT, or SGRT + fiducials) based on target position at the time of verification imaging using cone beam computed tomography. This was recorded as numerical values in centimeters for each directional shift, as well as a calculated vector composite of the directional shifts. Reliability was measured with each fraction.
Measured: from start of SBRT treatment to completion of SBRT treatment, median duration was 4 days
Reliability of Gated SBRT Treatments Utilizing SGRT vs. SGRT With Fiducials - Rotational Shifts
Measured shift deltas for each of the rotational (in degrees; roll, pitch, rotation) shifts were determined utilizing surface guided radiation therapy (SGRT, or SGRT + fiducials) based on target position at the time of verification imaging using cone beam computed tomography. This was recorded as numerical values in degrees for each rotational shift. Reliability was measured with each fraction.
Measured: from start of SBRT treatment to completion of SBRT treatment, median duration was 4 days
Local Control of Treated Tumor(s)
The outcome will be measured as the duration of time from enrollment to progression of the subject's treated tumor(s)
Measured: up to 24 months
Overall Survival
This outcome will be measured as the duration of time from the date of enrollment to the study to the date of death from any cause.
Measured: approx. 2 years
Change From Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Total Symptom + Interference Score
The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms. Arithmetic mean of the items completed was calculated to determine a mean total symptom + interference score ranging from 0 to 10. The mean score is reported if more than 50% of the items are completed on a given administration. Change from baseline was calculated as the post baseline timepoint mean score minus the baseline mean score for each participant. As higher scores indicate worse symptoms and more interference at a given timepoint, if the change from baseline is a positive value, this indicates a worsening of symptoms at the post-baseline timepoint.
Measured: From pre-SBRT to 1, 3, 6, and 12 months after the last treatment of SBRT (on average SBRT treatment lasted 4.8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start25 Sep 2019
- Primary completion18 Oct 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- John Heinzerling, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060927
- Sponsor's protocol ID
- IRB00081383
- Other IDs
- 00036616, LCI-LUN-SBRT-002
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2019
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI-LUN-SBRT-002: Pilot Study of SGRT Alone vs. SGRT in Combination With Fiducials for Breath Hold SBRT Treatments of the Lung
- ClinicalTrials.gov ID
- NCT04060927
- Acronym / sponsor ID
- IRB00081383
- Conditions
- Lung Cancer
- Keywords
- NSCLC, Lung, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.
Detailed description
The study's primary objective is estimate the incidence of SBRT and fiducial-related pulmonary toxicities for subjects treated with SBRT who have tumors that move ≥ 1 cm in 3 different cohorts: 1) free breathing with SGRT 2) breath hold utilizing SGRT only; 3) breath hold utilizing SGRT in combination with implanted fiducials. Secondary objectives also include Estimate reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials estimating local control for SBRT in subjects treated in the three different cohorts, estimating overall survival, and evaluating quality of life. A safety objective of estimating acute and long-term grade 2 or higher non-hematologic toxicities attributed to SBRT/fiducial implantation in subjects treated in the three different cohorts will also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: SGRTFreebreathing SBRT with SGRT |
| Group 2 | Experimental | Device: SGRTBreath hold SBRT with SGRT |
| Group 3 | Experimental | Device: SGRTBreath hold SBRT with SGRT in combination with implanted fiducials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent with HIPAA authorization for release of personal health information.
- Age ≥18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of fiducials in combination with SBRT in subjects <18 years of age, children are excluded from this study.
- ECOG Performance Status of ≤ 2.
- Stage IA-IIB (T1a-T3bN0) presumed non-small cell lung cancer, carcinoid tumors, or lung metastasis that have ≥ 1 cm of respiratory associated motion measured on 4DCT at time of simulation for SBRT with or without respiratory motion suppression techniques. Histologic confirmation of malignancy is encouraged but not required. Primary or metastatic tumor ≤ 7 cm.
Key exclusion criteria (3 listed)
- Prior radiation to the chest that would overlap with the current radiation fields and determined by the treating physician to impede the treatment of the study malignancy.
- Active ongoing pulmonary infection or pneumonitis that is requiring active treatment with antibiotics or steroids. Prior pneumonitis from drug or other therapies that has been treated within 15 days of first day of treatment.
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 |
|---|---|---|
| SGRTSurface Guided Radiation Therapy | Device | Group 1, Group 2, Group 3 |
Primary outcome
Number of Participants With Grade 2 or Higher SBRT-related Pulmonary Toxicities as Assessed by NCI CTCAE v.5.0
Time frame: from date of SBRT start or fiducial placement to 12 months after completion of SBRT treatment
A binary variable was determined for each participant indicating whether the participant experienced at least one grade 2 or higher pulmonary adverse event (according to NCI Common Terminology for Adverse Events version 5.0) during treatment or within 12 months after completion of SBRT that was determined to be related (possibly, probably, or definitely attributed) to SBRT.
Number of Participants With Grade 2 or Higher Fiducial-related Pulmonary Toxicities as Assessed by NCI CTCAE v.5.0
Time frame: from date of fiducial placement to 12 months after completion of SBRT treatment
A binary variable was determined for each participant indicating whether the participant experienced at least one grade 2 or higher pulmonary adverse event (according to NCI Common Terminology for Adverse Events version 5.0) during treatment or within 12 months after completion of SBRT that was determined to be related (possibly, probably, or definitely attributed) to implantation of fiducials.
5 secondary outcomes
Reliability of Gated SBRT Treatments Utilizing SGRT vs. SGRT With Fiducials - Directional Shifts
Time frame: from start of SBRT treatment to completion of SBRT treatment, median duration was 4 days
Reliability of Gated SBRT Treatments Utilizing SGRT vs. SGRT With Fiducials - Rotational Shifts
Time frame: from start of SBRT treatment to completion of SBRT treatment, median duration was 4 days
Local Control of Treated Tumor(s)
Time frame: up to 24 months
Overall Survival
Time frame: approx. 2 years
Change From Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Total Symptom + Interference Score
Time frame: From pre-SBRT to 1, 3, 6, and 12 months after the last treatment of SBRT (on average SBRT treatment lasted 4.8 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John Heinzerling, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGRT in people with Lung Cancer, run by Wake Forest University Health Sciences 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 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Grade 2 or Higher SBRT-related Pulmonary Toxicities as Assessed by NCI CTCAE v.5.0 (time frame: from date of SBRT start or fiducial placement to 12 months after completion of SBRT treatment). The study lists 2 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 29 Oct 2026.