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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06159660




Registration number
NCT06159660
Ethics application status
Date submitted
22/08/2023
Date registered
7/12/2023
Date last updated
14/12/2023

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
1/03/2024
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
The goal of this observational validation study is to determine the best implementation of
fluoroscopic and CT ventilation imaging in patients having non-stereotactic ablative body
radiotherapy (non-SABR) radiotherapy for stages II-IV lung cancer. The main questions it aims
to answer are:

- Assess the dosimetric variation in functional avoidance radiation therapy (RT) plans
produced using these ventilation imaging techniques,

- Establish a quality assurance procedure for functional lung avoidance radiation therapy,
and

- Evaluate the clinical acceptable thresholds for accuracy of the method.

Participants will:

Prior to radiation therapy treatment, patients will undergo:

1. A standard of care 4DCT scan for radiation therapy simulation,

2. Pulmonary Function Tests (PFT)

3. A 4D attenuation correction CT

4. Breath Hold Computed Tomography (BHCT) imaging where static end-inspiration and
end-expiration BHCT scans will be acquired,

5. Nuclear medicine imaging where a Tc-99m MAA SPECT perfusion scan and a Galligas PET
ventilation scan will be acquired,

6. Fluoroscopy where 1-breath cine-fluoroscope sequences will be acquired at five different
angles across the chest,

7. A 4D Cone Beam Computed Tomography (4DCBCT) scan.

8. Scans in points 4 to 7 above will be repeated at the end of treatment. Individual
participants provide their own internal control.

Galligas PET ventilation images (control) are compared with ventilation images derived from
additional scans (comparator) for each participant. Tc-99m MAA SPECT perfusion images
(control) are compared with perfusion images derived from BHCT scans (comparator) for each
patient.

There will be no change to patient treatment and patients will be treated using a standard of
care anatomical based treatment plan. The pre-treatment 4DCBCT scan is part of standard of
care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06159660
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06159660