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Search / Trial NCT04722263

Radiotherapy for Keloids

Launched by MONTEFIORE MEDICAL CENTER · Jan 21, 2021

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of radiation therapy to treat keloids, which are thick, raised scars that can develop after an injury or surgery. The goal is to see if this treatment is both safe and effective for patients whose keloids cannot be surgically removed or for those who choose not to have surgery. The trial is currently looking for participants aged 18 and older who have been diagnosed with a keloid and meet certain criteria, such as not having had previous radiation therapy in the same area.

If you join the study, you can expect to receive radiation therapy as part of your treatment. Before starting, you'll need to provide informed consent, which means you'll be fully informed about the trial and agree to participate. It's important to know that some people may not be eligible, especially if they have certain health conditions or if the keloid is located in a place where radiation could cause serious side effects. This is a great opportunity for individuals with keloids to explore a new treatment option.

Gender

ALL

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

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Keyur J Mehta, MD

Principal Investigator

Montefiore

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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