Bronchial Mapping (GCC 1635)

NCT02745548 | Terminated DMC

• 1 other identifier: HP-00069334
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thoracic Cancer

Keywords

Lung Cancer; NSCLC (Non Small Cell Lung Cancer); SABR (Stereotactic ablative radiotherapy)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Thoracic malignancies who consent to recieving Radiation treatment at the University of Maryland, Baltimore, will be offered this protocol design.

You may qualify if:

• 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

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 Maryland, Baltimore: lead

Study Sites (1)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Amit Sawant, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

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: April 8, 2016
• First Posted: April 20, 2016
• Study Start: June 1, 2017
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)