Novel Lung Functional Imaging for Personalized Radiotherapy

NCT02308709 | Completed Results DMC

• 2 other identifiers: 472677CCRO030
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.

Conditions

Lung Cancer

Keywords

Radiotherapy; Pulmonary Functional Imaging; Computed Tomography (CT); Image Registration; Functional Image-guided Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy

  Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.

  12 months

Secondary Outcomes (3)

• Radiation Pneumonitis Graded by CTCAE v4.0

  2 years

• Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and 6 months

• Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

  Baseline and 6 months

Study Arms (1)

Ventilation image-guided radiotherapy

EXPERIMENTAL

Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions

Radiation: Ventilation image-guided radiotherapy

Interventions

Ventilation image-guided radiotherapy RADIATION

Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Ventilation image-guided radiotherapy

Eligibility Criteria

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

You may qualify if:

• Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR).
• Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions.
• Concurrent chemotherapy is allowed, but not required.
• Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians.
• Zubrod performance status ≤2
• Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500; LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50
• Patient must be able to provide study specific informed consent prior to study entry.

You may not qualify if:

• Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields.
• For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible.
• For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system.
• Children (\<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, 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

Results Point of Contact

• Title: Analyst
• Organization: University of California, Davis

nlogihara@ucdavis.edu

916-734-8053

Study Officials

• Tokihiro Yamamoto, Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: December 4, 2014
• Study Start: September 15, 2014
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2021
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)