Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic … (NCT05459311) | Clinical Trial Compass
CompletedNot Applicable
Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR)
United States12 participantsStarted 2017-10-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Age ≥ 18 years. No gender or ethnic restrictions.
✓. ECOG performance status ≤ 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.
✓. 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.
Exclusion criteria
What they're measuring
1
The association between radiation-induced collapse of Branching Serial Structures (BSS) elements and localized change in pulmonary function.
Timeframe: 24 months
2
The radiosensitivity of peripheral Branching Serial Structures (BSS) segments.
Timeframe: 24 months
Trial details
NCT IDNCT05459311
SponsorUniversity of Texas Southwestern Medical Center