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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02070432
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Men or non-pregnant, non-breast feeding women
* Karnofsky performance status of 60% or greater
* Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck
* Clearly visible tumor on the oral cavity or cutaneous surface
Exclusion Criteria:
* Known hypersensitivity to any of the formulation ingredients
* Known hypersensitivity to porphyrins
* Porphyria or other diseases exacerbated by light
* Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site
* Planned skin phototherapy session(s) within the study timeframe
* Planned surgical procedure within the study timeframe
* Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe
* Existing therapy with a photosensitizing agent
* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening
* Myocardial infarction within 6 months prior to screening
* Contraindication to MRI with gadolinium
* Unacceptable laboratory abnormalities
* Clinically relevant 12-lead ECG abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02070432
Study Brief:
Protocol Section:
NCT02070432