Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy (SAbR)

NCT05459311 | Completed DMC

• 1 other identifier: STU-062016-073
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Thoracic Cancer

Outcome Measures

Primary Outcomes (2)

• The association between radiation-induced collapse of Branching Serial Structures (BSS) elements and localized change in pulmonary function.

  Evaluating the association between radiation-induced collapse of Branching Serial Structures (BSS) elements, characterized by segmental collapse, and localized change in pulmonary function. a map of collapsed and open BSS elements will be generated from the contoured BSS trees in the pre- and post-SAbR BHCT scans to determine the impact of radiation-induced collapse of BSS elements and localized changes to pulmonary function.

  24 months

• The radiosensitivity of peripheral Branching Serial Structures (BSS) segments.

  Evaluating the radiosensitivity of peripheral BSS segments in terms of dose dependent probability of collapse through Generalized Estimating Equation (GEE).

  24 months

Secondary Outcomes (1)

• Create intensity modulated radiotherapy treatment plans

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Lung/Thoracic malignancies who consent to recieving Radiation treatment at the University of Texas Medical Center, will be offered this protocol design.

You may qualify if:

• 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.
• 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).

You may not qualify if:

• Children (age \<18 years).
• Women who are pregnant, nursing, or trying to get pregnant
• ECOG performance status \> 3

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Cancer Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: July 14, 2022
• Study Start: October 3, 2017
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

US (1)