Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinically diagnosed keloid
• Surgical excision of keloid is either contraindicated or patient has declined treatment with surgical excision (Note: patients with keloids that recurred after previous resection are eligible, as long as the current keloid is either unresectable or patient has declined resection)
• Age ≥ 18
• Study specific informed consent provided
Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Daniel Alicea
daniel.alicea2@einsteinmed.edu
646-538-9909
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 15
Treatments
Experimental: Radiotherapy for patients with nonresectable keloids
Patients will be seen by a treating radiation oncologist and treatment with the assigned dose schedule will be planned using either EBRT with electrons or high dose-rate radiotherapy (HDR) brachytherapy as deemed appropriate by the treating radiation oncologist. The treatment dose of 15 Gy in 3 fractions will be prescribed to the 90% isodose line.
Authors
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center