Thoracic CancerNCT02745548
Bronchial Mapping (GCC 1635)
An observational study of Thoracic Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
In order to better understand radiation-induced lung toxicity, the investigator proposes a novel functional avoidance approach that incorporates central as well as peripheral BSS segments in the treatment planning process in order to quantify and account for their respective radiosensitivities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic Cancer
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 2 Oct 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.
Who may be able to join
- Patients with primary or metastatic lung lesions to be treated using stereotactic ablative radiotherapy (There is no limitation on the location or number of lesions for this study) OR Conventionally fractionated RT patients with primary or metastatic lung lesions
- Age ≥ 18 years. No gender or ethnic restrictions.
- Performance status ECOG ≥ 3
- Ability to hold breath for ~20 seconds
- Ability to understand and the willingness to sign a written informed consent.
- Any types and amounts of prior therapy will be allowed for this study.
- Maximum PTV dimension ≤ 70 mm
Who cannot join
- Children (age <18 years).
- Women who are pregnant, nursing, or trying to get pregnant.
- ECOG performance status < 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR)
In order to better understand radiation-induced lung toxicity, the investigator proposes a novel functional avoidance approach that incorporates central as well as peripheral BSS segments in the treatment planning process in order to quantify and account for their respective radiosensitivities. Specifically, the investigator proposes a systematic study that involves acquiring pre- and post-SAbR high-resolution CT and SPECT V/Q scans from lung cancer patients who receive radiotherapy, followed by auto-segmentation of the BSS elements using virtual bronchoscopy.
Read the detailed description
Very few recent lung cancer therapies have had as positive an impact on public health as lung SAbR. Lung SAbR involves the precise administration of very high, biologically potent doses (54-70 Gy) in 3-5 fractions. The most recent update of the Radiation Therapy Oncology Group (RTOG) 0236 Phase II multi-center lung SAbR trial showed 5-year primary tumor control >90% in inoperable Stage I NSCLC patients with tumors ≤ 5cm. However, the use of such highly potent doses puts patients at risk for collateral toxicity including radiation pneumonitis and radiation injury to airways, causing stenosis, atelectasis and ultimately fibrosis. A review of 35 early-stage NSCLC SAbR clinical studies found that the reported maximum values of Grade ≥3 toxicities were between 10-28%. In the RTOG 0236 trial, 17% patients presented Grade ≥3 toxicities. Furthermore, toxicity has been shown to increase dramatically for centrally-located and/or larger (> 5cm) early-stage tumors. Due to these concerns, in current clinical practice, the use of high-dose-per-fraction lung SAbR is routinely indicated only for a small percentage (~3 - 4%) of the NSCLC population - inoperable, early-stage patients with small, peripheral lesions. Inoperable patients with early-stage central and/or larger tumors, higher stage and/or multiple lesions, and pulmonary oligometastases (metastatic disease that is limited in number of lesions and sites) are either treated with conventional radiotherapy and/or chemotherapy (~30 - 40% 5-year survival), or not treated (median survival ~1 year).
The segmented structures will be imported into a clinical radiotherapy treatment planning system in order to calculate dose to individual BSS elements. Follow-up CT images and follow-up SPECT V/Q scans will be used to characterize the radiosensitivity of these structures and spatially map the potential radiation-induced loss of lung function. Eventually, using this information, the investigator will investigate treatment planning strategies that help limit radiation dose and consequent damage to BSS elements, thereby reducing lung toxicity. The investigator hypothesizes that - Anatomically variable radiation injury to the bronchial tree and pulmonary vasculature is an important determinant of post-SAbR pulmonary toxicity and residual pulmonary function.
- Conditions
- Thoracic Cancer
- Keywords
- Lung Cancer, NSCLC (Non Small Cell Lung Cancer), SABR (Stereotactic ablative radiotherapy)
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that show an association between radiation-induced collapse of branching serial structures elements and localized change in pulmonary function
Evaluating the association of RT and how branching structures change in lung function
Measured: 3 years
Radiosensitivity of peripheral BSS segments in terms of dose dependent probability of collapse.
Evaluating the difference between dose and segmental collapse with pre- and post treatment MRI's
Measured: 3 years
Secondary outcomes (1)
Number of patients analyzed for creation of intensity modulated radiotherapy treatment plans that incorporate radiation dose thresholds for BSS elements
Evaluating IMRT plans incorporated radiation dose thresholds for BSS elements
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start1 Jun 2017
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Why it stopped: Grant ended, slow accrual- enrollment goal not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Amit Sawant, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745548
- Sponsor's protocol ID
- HP-00069334
- Status last verified
- May 2025
- First submitted
- 8 Apr 2016
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR)
- ClinicalTrials.gov ID
- NCT02745548
- Acronym / sponsor ID
- HP-00069334
- Conditions
- Thoracic Cancer
- Keywords
- Lung Cancer, NSCLC (Non Small Cell Lung Cancer), SABR (Stereotactic ablative radiotherapy)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Grant ended, slow accrual- enrollment goal not met.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 20 Apr 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.
In order to better understand radiation-induced lung toxicity, the investigator proposes a novel functional avoidance approach that incorporates central as well as peripheral BSS segments in the treatment planning process in order to quantify and account for their respective radiosensitivities. Specifically, the investigator proposes a systematic study that involves acquiring pre- and post-SAbR high-resolution CT and SPECT V/Q scans from lung cancer patients who receive radiotherapy, followed by auto-segmentation of the BSS elements using virtual bronchoscopy.
Detailed description
Very few recent lung cancer therapies have had as positive an impact on public health as lung SAbR. Lung SAbR involves the precise administration of very high, biologically potent doses (54-70 Gy) in 3-5 fractions. The most recent update of the Radiation Therapy Oncology Group (RTOG) 0236 Phase II multi-center lung SAbR trial showed 5-year primary tumor control >90% in inoperable Stage I NSCLC patients with tumors ≤ 5cm. However, the use of such highly potent doses puts patients at risk for collateral toxicity including radiation pneumonitis and radiation injury to airways, causing stenosis, atelectasis and ultimately fibrosis. A review of 35 early-stage NSCLC SAbR clinical studies found that the reported maximum values of Grade ≥3 toxicities were between 10-28%. In the RTOG 0236 trial, 17% patients presented Grade ≥3 toxicities. Furthermore, toxicity has been shown to increase dramatically for centrally-located and/or larger (> 5cm) early-stage tumors. Due to these concerns, in current clinical practice, the use of high-dose-per-fraction lung SAbR is routinely indicated only for a small percentage (~3 - 4%) of the NSCLC population - inoperable, early-stage patients with small, peripheral lesions. Inoperable patients with early-stage central and/or larger tumors, higher stage and/or multiple lesions, and pulmonary oligometastases (metastatic disease that is limited in number of lesions and sites) are either treated with conventional radiotherapy and/or chemotherapy (~30 - 40% 5-year survival), or not treated (median survival ~1 year).
The segmented structures will be imported into a clinical radiotherapy treatment planning system in order to calculate dose to individual BSS elements. Follow-up CT images and follow-up SPECT V/Q scans will be used to characterize the radiosensitivity of these structures and spatially map the potential radiation-induced loss of lung function. Eventually, using this information, the investigator will investigate treatment planning strategies that help limit radiation dose and consequent damage to BSS elements, thereby reducing lung toxicity. The investigator hypothesizes that - Anatomically variable radiation injury to the bronchial tree and pulmonary vasculature is an important determinant of post-SAbR pulmonary toxicity and residual pulmonary function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.
Key inclusion criteria (7 listed)
- Patients with primary or metastatic lung lesions to be treated using stereotactic ablative radiotherapy (There is no limitation on the location or number of lesions for this study) OR Conventionally fractionated RT patients with primary or metastatic lung lesions
- Age ≥ 18 years. No gender or ethnic restrictions.
- Performance status ECOG ≥ 3
- Ability to hold breath for ~20 seconds
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (3 listed)
- Children (age <18 years).
- Women who are pregnant, nursing, or trying to get pregnant.
- ECOG performance status < 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients that show an association between radiation-induced collapse of branching serial structures elements and localized change in pulmonary function
Time frame: 3 years
Evaluating the association of RT and how branching structures change in lung function
Radiosensitivity of peripheral BSS segments in terms of dose dependent probability of collapse.
Time frame: 3 years
Evaluating the difference between dose and segmental collapse with pre- and post treatment MRI's
1 secondary outcome
Number of patients analyzed for creation of intensity modulated radiotherapy treatment plans that incorporate radiation dose thresholds for BSS elements
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Grant ended, slow accrual- enrollment goal not met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- 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.
Amit Sawant, PhD principal investigator
University of Maryland, Baltimore
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 Thoracic Cancer, run by University of Maryland, Baltimore 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 7 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: stopped early, as of the sponsor's last update on 15 May 2025. 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 was stopped early (reason given: Grant ended, slow accrual- enrollment goal not met.). Results are not available in the source record.
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 patients that show an association between radiation-induced collapse of branching serial structures elements and localized change in pulmonary function (time frame: 3 years). 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 15 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.