Pre- and post-treatment evaluation of lung function with Xenon-gas enhanced Dual-Energy CT-imaging in patients undergoing radiotherapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2025-10-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Diagnosis

The primary objective of this trial is to acquire high-resolution anatomical and functional information on lung ventilation using a gas mixture of 30 Vol% Xe in 70 Vol% O2 as contrast agent in combination with DECT-imaging in lung and breast cancer patients scheduled to undergo radiotherapy. Ventilation maps will be generated to evaluate the effect of radiotherapy on the lung parenchyma in lung and breast cancer patients.

Secondary objectives 1

1. Our secondary objective constitutes the aim to qualitatively (visual) and quantitatively assess differences in ventilation patterns between pre- and post-treatment ventilation maps, identifying and evaluating areas affected by treatment on a regional level.

Conditions and MedDRA coding

Radiation-induced lung injury (radiation fibrosis, radiation pneumonitis)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Lung and breast cancer having a TNM classification I-IIIa.
2. Between 50 and 80 years old.
3. No prior cancer treatment.
4. Breath hold for 3 seconds
5. Patients who are in stable condition or who are not hospitalized in an ICU.
6. Patients who are not suffering from COPD GOLD IV.
7. Patients who signed informed consent forms.

Exclusion criteria 7

1. No lung or breast cancer having a TNM classification I-IIIa.
2. Younger than 50 or older than 80 years old.
3. Received prior cancer treatment.
4. Cannot perform a 3 s breath hold
5. Patients who are in an unstable condition or who are hospitalized in ICU.
6. Patients who are suffering from COPD GOLD IV.
7. Patients who did not sign informed consent forms.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is to quantify radiotherapy-induced functional and anatomical changes by comparing pre- and post-treatment ventilation maps. Radiotherapy-induced changes will be assessed both qualitatively, by visual analysis of differences in lung parenchyma structure and ventilation patterns (hypo- or hyperdense areas on colour coded Xe-concentration maps of the lungs), and quantitatively, by computing local differences in ventilation metrics between pre- and post-treatment.

Secondary endpoints 1

1. The secondary endpoint of this trial is to perform an extensive evaluation on the effect of RT on the lung parenchyma of lung- and breast cancer patients using ventilation metrics derived using a gas mixture of 30Vol% Xe in 70Vol% O2 as contrast agent combined with DECT.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Nico Buls

Public contact point

Organisation

UZ Brussel

Contact name

Emma Verelst

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications