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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06159660




Registration number
NCT06159660
Ethics application status
Date submitted
22/08/2023
Date registered
7/12/2023

Titles & IDs
Public title
Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy
Scientific title
Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy
Secondary ID [1] 0 0
IX-2023-OV-VENTURE
Universal Trial Number (UTN)
Trial acronym
VENTURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physiological accuracy of X-ray-based ventilation imaging (BHCT, fluoroscopy, 4DCBCT, 4DCT)
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Difference in mean dose to high functioning lung structures between avoidance treatment plans and standard of care anatomical based treatment plans.
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Difference in percentage volume of high functioning lung structures receiving 20 Gray (20Gy) or more between functional lung avoidance treatment plans and standard of care anatomical based treatment plans.
Timepoint [2] 0 0
1 week
Secondary outcome [3] 0 0
Reduction in predicted risk of grade 2+ radiation pneumonitis (CTCAE v5) in functional lung avoidance treatment plans compared to standard of care anatomical based treatment plans.
Timepoint [3] 0 0
1 week
Secondary outcome [4] 0 0
Increased burden in the radiotherapy workflow involved with creating functional lung avoidance treatment plans.
Timepoint [4] 0 0
2 weeks
Secondary outcome [5] 0 0
Change in ventilation from lung radiation therapy.
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Physiological accuracy of CT perfusion imaging
Timepoint [6] 0 0
1 week
Secondary outcome [7] 0 0
Improvement in 4D PET image reconstruction using 4D attenuation CT
Timepoint [7] 0 0
1 week

Eligibility
Key inclusion criteria
* Aged 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Histologically proven Stage II-IV non-small cell lung cancer as determined using the IASLC International Association for the Study of Lung Cancer (IASLC) 8th edition lung cancer staging guidelines.
* To be treated with curative intent (stage II-III) or palliative intent (stage IV) with non-SABR external beam radiotherapy (e.g. 60 Gy in 30 treatments for curative intent or 30 Gy in 5 treatments for palliative intent).
* Pulmonary function tests within 8 weeks of registration.
* 4DCT simulation for radiation therapy.
* Willingness to give written informed consent.
* Willingness and ability to comply with the study procedures and visit requirements.
* Available for follow up for 1 year or until death, whichever occurs first.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior radiation therapy to the thorax.
* Prior surgery for this cancer.
* Prior chemotherapy for this cancer.
* Interstitial lung disease.
* Pregnant women.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Sydney and Central Coast Area Health Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ricky O'Brien
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Coordinator
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1185
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06159660