Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-24 @ 8:01 PM
NCT ID:
NCT03346304
Eligibility Criteria:
Inclusion Criteria:
1. Patients with ≥1 histologically confirmed lung HGL (defined as severe dysplasia or carcinoma in situ) PRE-REGISTRATION: High likelihood of presence of lung HGLs as evaluated by investigator (e.g. because patient part of existing surveillance cohort or referred to trial site) and inclusion/exclusion criteria below. PRE-RANDOMISATION: Following registration and AFB, only patients with ≥1 lung HGLs confirmed histologically can be continue to randomisation provided they continue to meet inclusion/exclusion criteria below.
2. Absence of metastatic disease or other primary cancers as confirmed by CT thorax within 28 days prior to registration only)
3. Male or female patients ≥18 years of age
4. No upper age limit but life expectancy must be at least 3 years
5. ECOG Performance Score 0-2
6. FEV1 ≥ 25% of predicted
7. DLCO/TLCO ≥ 20% of predicted (within 28 days prior to registration only)
8. Women of child-bearing potential (WOCBP), or men with female partners who are pregnant or WOCBP must be willing to practise highly effective methods of birth control starting as soon as possible from the time of informed consent and registration until randomisation (if randomised to the control arm), or until 3 months after the end of their last PDT treatment (if randomised to the intervention arm) . Male patients must also advise their female partners who are WOCBP regarding contraceptive requirements as listed for female patients who are WOCBP.
9. Patients who are WOCBP must also have a negative pregnancy test at the following time points:
* within 14 days prior to registration
* within 21 days prior to randomisation
* and within 24 hours prior to 1st and 2nd PDT treatment, for each lung treated (only if randomised to PDT arm)
10. Ability to give informed consent including the donation of biological samples for translational research
Exclusion criteria:
1. PRE-RANDOMISATION: Finding of (micro)-invasive disease on histology
2. HGLs present for ≥5 years which have remained stable on autofluorescence bronchoscopy (AFB) surveillance
3. Detection of active cancer or on systemic treatment for cancer, excluding basal cell skin cancers (unless adjacent to the illumination site)
4. Previous radiotherapy to the central airways
5. ECOG Performance Score \>2
6. Patients who are anticoagulated for prosthetic heart valves
7. Decompensated heart disease with life expectancy less than 3 years
8. Severe liver and renal insufficiency with life expectancy less than 3 years
9. Porphyria or hypersensitivity against porphyrins or photosensitivity
10. Hypersensitivity to chlorine-e6-trisodium salt or therapy with another photosensitising agent or relevant antibiotics (macrolides) in the last 4 weeks
11. Ophthalmic disease likely to require slit-lamp examination within 60 days of registration/randomisation
12. Planned surgical procedure within 60 days of registration/randomisation
13. Patient unlikely to cooperate with a 3-year follow-up; medical or psychological condition at the discretion of the investigator which would not permit compliance with the protocol or meaningful signed informed consent
14. Participation in another study with an investigational medicinal product within one month prior to registration/randomisation
15. Pregnant or breast feeding women (confirmed by serum/urine ß-HCG)
16. Any other condition which is assessed as an intolerable risk by the investigator upon inclusion in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03346304
Study Brief:
Protocol Section:
NCT03346304