Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II
ConditionNEUROFIBROMATOSIS 1
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-30
SponsorDonald Basel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Life expectancy less than 3 years.
Pregnancy.
Cutaneous photosensitivity to the wavelengths used to active PDT.
A diagnosis of porphyria.
Trial design
Design model
Single group
Treatments tested in this trial
aminolevulinic acid
DrugDrug: Levulan Kerastick Drug: Topical placebo Device: Omnilux Revive Procedure: Photodynamic therapy Other: Tumor growth rate measurements
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: PDT TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to disease progression
The time it takes for 50% growth in tumor size over baseline measurements.
Time frame
3 yearsSecondary outcomes
1
Tumor growth rate
Measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Donald Basel
Lead sponsor
Medical College of Wisconsin
Sponsor institution
Source ClinicalTrials.gov