NCT05134558

Brief Summary

The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 26, 2021

Status Verified

September 1, 2021

Enrollment Period

4.9 years

First QC Date

September 22, 2021

Last Update Submit

November 14, 2021

Conditions

Lung CancerRadiation Therapy Complication

Keywords

lung cancerRadiation TherapyXenon-enhanced ventilation CT

Outcome Measures

Primary Outcomes (1)

  • Incidence of radiation pneumonia

    Incidence of radiation pneumonia

    Within 1 year of radiation therapy

Study Arms (1)

Xenon-enhanced Ventilation CT-guided Radiotherapy

EXPERIMENTAL

Patients will be receiving Xenon-enhanced Ventilation CT-guided Radiotherapy for functional lung avoidance. The doses for the tumors, lungs, and organs at risk will be examined and evaluated.

Radiation: Xenon-enhanced Ventilation CT-guided Radiotherapy

Interventions

Xenon-enhanced Ventilation CT-guided RadiotherapyRADIATION

Xenon-enhanced Ventilation CT-guided Radiotherapy for functional protection of the lung

Xenon-enhanced Ventilation CT-guided Radiotherapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20-80 years, with lung cancer receiving thoracic radiotherapy in NTUH, from February 2020 to December 2024.

You may not qualify if:

  • The age is less than 20 years old or older than 80 years old.
  • Unstable clinical condition, unable to maintain apnea for 15 second, and history of prior adverse reaction to xenon.
  • Renal insufficiency patients.
  • Claustrophobia
  • Those who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Yu-Sen Huang, Md PhD

CONTACT

+886-23123456yusen0814@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

November 26, 2021

Study Start

February 4, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 26, 2021

Record last verified: 2021-09

Locations

TW(1)