Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II
Megadott ok: data analysis unequivocal - requires study methodology re-evaluation
Key facts
- Where
- Milwaukee, Egyesült ÁllamokSee the site
- Phase
- 2. fázis
Where in Egyesült Államok
- Donald G BaselMilwaukee, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Donald Basel
- Trial code
- NCT02728388
- Record updated
- 2026. július 10.
- Original description
The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1).Read full original descriptionShow less
Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II
The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1).
The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.
Inclusion: Patient is 14 years or older; Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section); Tumor Location: cutaneous, trunk, or limbs only; Tumor Type: superficial dermal neurofibromas ≤4mm deep; Patient has provided written informed consent; Patient is willing to and can comply with study follow-up requirements; Absence of any other malignancy.
Exclusion: Previous chemotherapy within 6 weeks of proposed PDT; Other concurrent tumor therapy; Allergy to aminolevulinic acid or any of the topical solution vehicle components; Life expectancy less than 3 years; Pregnancy; Cutaneous photosensitivity to the wavelengths used to active PDT; A diagnosis of porphyria.