KeloidSkinBones and jointsRadiation
What this study is
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
What's being tested
- Radiotherapy
Intervention · RADIATION
25 Gy in 5 fractions
Study details
- Official title
- Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
- Sponsor
- Montefiore Medical Center
- Conditions
- Keloid
- Enrolling
- 15 people
- Starts
- 2020-12-01
- Est. completion
- 2027-04
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openMontefiore Medical Center
The Bronx, New York, United States
- Keyur Mehta, MD · Contact718-920-5636kmehta@montefiore.org
Recruiting
Study team
Sponsor
Montefiore Medical Center
Study ID 2020-11620
Principal investigator
Keyur J Mehta, MD
Montefiore
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.