Radiation therapy for treating keloids
Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
NA · Montefiore Medical Center · NCT04722263
This study is testing if radiation therapy can safely help people with stubborn keloids by reducing their size and improving their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT04722263 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the safety and efficacy of radiation therapy (RT) for patients with unresected keloids. It will be conducted at a single institution and will focus on assessing toxicity within 10 weeks, as well as secondary outcomes such as keloid growth cessation, size reduction, symptomatic relief, and quality of life improvements. Patients will receive RT in the form of external beam radiotherapy or brachytherapy, with a total dose of 15 Gy delivered in fractions over three days. The study plans to recruit 15-20 patients over a period of 6-12 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinically diagnosed unresected keloids who cannot undergo surgical excision.
Not a fit: Patients with prior radiation therapy to the treatment area or those with uncontrolled illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for patients suffering from keloids, potentially improving their quality of life.
How similar studies have performed: While there is existing literature on the use of radiation therapy for keloids, this specific approach is being evaluated in a pilot setting, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Keyur J Mehta, MD — Montefiore
- Study coordinator: Daniel Alicea
- Email: daniel.alicea2@einsteinmed.edu
- Phone: 646-538-9909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keloid