Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR)
We will conduct a prospective clinical study involving up to 40 non-Small Cell Lung Cancer (nSCLC) patients to determine dose thresholds for central and peripheral BSS elements. All imaging will be performed under motion control (e.g., with or without abdominal compression) defined as breathing with a resultant motion ≤5mm by fluoroscopy. In this study, a high-resolution breath-hold CT scan (BHCT) will be acquired from each patient immediately before or after the 4DCT scan. A follow-up high resolution BHCT (also under motion control) will be acquired from each patient 8-12 months post-SabR, and BSS elements will be segmented in LungPointRT. A radiation oncologist will compare the pre- and post-SabR contours to determine segmental collapse.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 4, 2023 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- University of Texas Southwestern Medical Center
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 1. Patients with primary or metastatic lesions in the lung, to be treated with definitive proton or photon radiotherapy. There is no limitation on the number of radiotherapy fractions, or the location/number of lesions for this study 2. Age ≥ 18 years. No gender or ethnic restrictions. 3. ECOG performance status ≤ 3 4. Ability to hold breath for \~20 seconds 5. Ability to understand and the willingness to sign a written informed consent. 6. Any types and amounts of prior therapy will be allowed for this study. 7. All men, as well as women of child-bearing potential must agree to use adequate contraception (surgical sterilization \[hysterectomy or vasectomy\], approved hormonal contraceptives \[birth control pills, patch or ring, Depo-Provera, Implanon\] or barrier method such as condom or diaphragm with spermicide or an intrauterine device) from consent until the end of study scans. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
1. Children (age \<18 years). 2. Women who are pregnant, nursing, or trying to get pregnant 3. ECOG performance status \> 3
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UT Southwestern Cancer CenterDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 4, 2023. Always confirm current availability with the study team.