Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

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). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

Conditions

NEUROFIBROMATOSIS 1

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Study Overview

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Study Details

Study overview

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.

Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II

Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

Condition
NEUROFIBROMATOSIS 1
Intervention / Treatment

-

Contacts and Locations

Milwaukee

Donald G Basel, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patient is 14 years or older.
  • 2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section).
  • 3. Tumor Location: cutaneous, trunk, or limbs only.
  • 4. Tumor Type: superficial dermal neurofibromas ≤4mm deep.
  • 5. Patient has provided written informed consent.
  • 6. Patient is willing to and can comply with study follow-up requirements.
  • 7. Absence of any other malignancy.
  • 1. Life expectancy less than 3 years.
  • 2. Pregnancy.
  • 3. Cutaneous photosensitivity to the wavelengths used to active PDT.
  • 4. A diagnosis of porphyria.
  • 5. Allergy to aminolevulinic acid or any of the topical solution vehicle components.
  • 6. Previous chemotherapy within 6 weeks of proposed PDT.
  • 7. Other concurrent tumor therapy.

Ages Eligible for Study

14 Years to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Donald Basel,

Donald G Basel, MD, STUDY_DIRECTOR, Medical College of Wisconsin

Study Record Dates

2025-12