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Recruiting
NCT04722263
Radiotherapy for Keloids
Conditions: Keloid
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Montefiore Medical Center
Location: Montefiore Medical Center The Bronx New York
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Prior RT to the area of interest that would result in overlap of radiation therapy fields
* Females of child bearing age without a negative serum pregnancy test prior to initiation of RT or unwilling to use contraception prior to and during the radiation course
* Keloids in areas where radiation therapy introduces unacceptable high risk of toxicity as determined by the treating radiation oncologist
* Uncontrolled intercurrent illness (e.g. symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or psychiatric situation) that would limit compliance with study requirements as judged by the treatment physicians
Source: ClinicalTrials.gov (NCT04722263). StuddyBuddy aggregates publicly available trial information.