KeloidNCT04722263
Radiotherapy for Keloids
A study testing Radiotherapy in people with Keloid, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Keyur Mehta, MD, 718-920-5636, kmehta@montefiore.org
About this study
Official title: Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Read the detailed description
This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids.
Primary Objective:
Evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids.
Secondary Objectives:
- To evaluate toxicity of RT for the treatment of unresected keloids.
- To evaluate response of keloids, either stability or decrease in size, after primary RT.
- To evaluate symptomatic response of unresected keloids to primary RT.
- To assess the effect on quality of life of primary RT for unresected keloids
After review of the literature on the use of RT for the treatment of keloids, both resected and unresected, as well as input of expert opinion and clinical experience by the study's radiation oncologists, the RT prescription dose for this study was selected to be 15 Gy, which will be divided into 5 Gy fractions delivered daily over on 3 consecutive days.
Patients will receive RT using external beam radiotherapy (EBRT), delivered via either electrons or megavoltage photons, or brachytherapy; RT modality will be based on the judgment of the treating radiation oncologist. The investigator team estimates that 15-20 patients will be able to be recruited. In successive intervals of enrollment and treatment of 5 patients (i.e., after 5, 10, and 15 patients have been enrolled), the study team will meet and perform interim analysis to evaluate the safety and efficacy of treatment. Investigators will discuss rates of toxicity and symptom management observed up to that point and determine if the study dose or protocol needs to be altered.
Patients will be evaluated frequently for treatment-related toxicities using CTCAE v5.0 up to 1 year after completion of RT. Any adverse event will be considered by the study investigators to evaluate the safety of the protocol and to determine whether changes to the dosing regimen are required.
Once patients have been identified as having a keloid that will not be surgically resected they will be referred to the radiation oncology department at Montefiore Medical Center. 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.
Amendment for increased dose (3/2023): The treatment dose of 25 Gy in 5 fractions will be prescribed to the 90% isodose line. Treatments will be given on consecutive days (Monday through Friday not including weekends), and all efforts will be made to not introduce a weekend break if at between treatment fractions.
- Conditions
- Keloid
- Being tested
- Radiotherapy
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Radiation therapy
25 Gy in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy for patients with nonresectable keloids | Experimental | 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 25 Gy in 5 fractions will be prescribed to the 90% isodose line. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related toxicities
The number of patients with treatment related toxicities will be determined by the incidence of grade 2 or higher skin-related adverse events based on CTCAE V5.0 criteria during prescheduled study visits. The number of patients with treatment related toxicities will be reported in aggregate for all visits.
Measured: Up to 1 year (+/- 1 month) post radiotherapy
Secondary outcomes (10)
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Measured: Week 0, during treatment (as close to the end of the radiotherapy course as practicable
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Measured: Up to 2 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Measured: Up to 6 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Measured: Up to 10 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Measured: Up to 6 months (+/- 1 month) post radiotherapy
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Measured: Up to 1 year (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Measured: During treatment. Assessed as close to the end of the radiotherapy course as practicable, up to ~1 week
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Measured: Up to 10 weeks (+/- 1 week) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Measured: Up to 6 months (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Measured: Up to 1 year (+/- 1 month) post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Dec 2020
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keyur J Mehta, MD, Principal investigator, Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722263
- Sponsor's protocol ID
- 2020-11620
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2021
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guix B, Henriquez I, Andres A, Finestres F, Tello JI, Martinez A. Treatment of keloids by high-dose-rate brachytherapy: A seven-year study. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):167-72. doi: 10.1016/s0360-3016(00)01563-7.
PubMed 11316560Mankowski P, Kanevsky J, Tomlinson J, Dyachenko A, Luc M. Optimizing Radiotherapy for Keloids: A Meta-Analysis Systematic Review Comparing Recurrence Rates Between Different Radiation Modalities. Ann Plast Surg. 2017 Apr;78(4):403-411. doi: 10.1097/SAP.0000000000000989.
PubMed 28177974Borok TL, Bray M, Sinclair I, Plafker J, LaBirth L, Rollins C. Role of ionizing irradiation for 393 keloids. Int J Radiat Oncol Biol Phys. 1988 Oct;15(4):865-70. doi: 10.1016/0360-3016(88)90119-8.
PubMed 3182326Bijlard E, Timman R, Verduijn GM, Niessen FB, Hovius SER, Mureau MAM. Intralesional cryotherapy versus excision with corticosteroid injections or brachytherapy for keloid treatment: Randomised controlled trials. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):847-856. doi: 10.1016/j.bjps.2018.01.033. Epub 2018 Feb 6.
PubMed 29426811Cheraghi N, Cognetta A Jr, Goldberg D. RADIATION THERAPY for the Adjunctive Treatment of Surgically Excised Keloids: A Review. J Clin Aesthet Dermatol. 2017 Aug;10(8):12-15. Epub 2017 Aug 1.
PubMed 28979658Renz P, Hasan S, Gresswell S, Hajjar RT, Trombetta M, Fontanesi J. Dose Effect in Adjuvant Radiation Therapy for the Treatment of Resected Keloids. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):149-154. doi: 10.1016/j.ijrobp.2018.05.027. Epub 2018 May 17.
PubMed 29970316Goutos I, Ogawa R. Brachytherapy in the adjuvant management of keloid scars: literature review. Scars Burn Heal. 2017 Nov 10;3:2059513117735483. doi: 10.1177/2059513117735483. eCollection 2017 Jan-Dec.
PubMed 29799578Rossi AM, Nehal KS, Lee EH. Radiation-induced Breast Telangiectasias Treated with the Pulsed Dye Laser. J Clin Aesthet Dermatol. 2014 Dec;7(12):34-7.
PubMed 25584136Malaker K, Vijayraghavan K, Hodson I, Al Yafi T. Retrospective analysis of treatment of unresectable keloids with primary radiation over 25 years. Clin Oncol (R Coll Radiol). 2004 Jun;16(4):290-8. doi: 10.1016/j.clon.2004.03.005.
PubMed 15214654Kim J, Lee SH. Therapeutic results and safety of postoperative radiotherapy for keloid after repeated Cesarean section in immediate postpartum period. Radiat Oncol J. 2012 Jun;30(2):49-52. doi: 10.3857/roj.2012.30.2.49. Epub 2012 Jun 30.
PubMed 22984682Lo TC, Seckel BR, Salzman FA, Wright KA. Single-dose electron beam irradiation in treatment and prevention of keloids and hypertrophic scars. Radiother Oncol. 1990 Nov;19(3):267-72. doi: 10.1016/0167-8140(90)90153-n.
PubMed 2126387Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10. doi: 10.1007/BF02737863. Epub 2001 Mar 21.
PubMed 11443481
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
- ClinicalTrials.gov ID
- NCT04722263
- Acronym / sponsor ID
- 2020-11620
- Conditions
- Keloid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Detailed description
This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids.
Primary Objective:
Evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids.
Secondary Objectives:
- To evaluate toxicity of RT for the treatment of unresected keloids.
- To evaluate response of keloids, either stability or decrease in size, after primary RT.
- To evaluate symptomatic response of unresected keloids to primary RT.
- To assess the effect on quality of life of primary RT for unresected keloids
After review of the literature on the use of RT for the treatment of keloids, both resected and unresected, as well as input of expert opinion and clinical experience by the study's radiation oncologists, the RT prescription dose for this study was selected to be 15 Gy, which will be divided into 5 Gy fractions delivered daily over on 3 consecutive days.
Patients will receive RT using external beam radiotherapy (EBRT), delivered via either electrons or megavoltage photons, or brachytherapy; RT modality will be based on the judgment of the treating radiation oncologist. The investigator team estimates that 15-20 patients will be able to be recruited. In successive intervals of enrollment and treatment of 5 patients (i.e., after 5, 10, and 15 patients have been enrolled), the study team will meet and perform interim analysis to evaluate the safety and efficacy of treatment. Investigators will discuss rates of toxicity and symptom management observed up to that point and determine if the study dose or protocol needs to be altered.
Patients will be evaluated frequently for treatment-related toxicities using CTCAE v5.0 up to 1 year after completion of RT. Any adverse event will be considered by the study investigators to evaluate the safety of the protocol and to determine whether changes to the dosing regimen are required.
Once patients have been identified as having a keloid that will not be surgically resected they will be referred to the radiation oncology department at Montefiore Medical Center. 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.
Amendment for increased dose (3/2023): The treatment dose of 25 Gy in 5 fractions will be prescribed to the 90% isodose line. Treatments will be given on consecutive days (Monday through Friday not including weekends), and all efforts will be made to not introduce a weekend break if at between treatment fractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy for patients with nonresectable keloids | Experimental | Radiation: RadiotherapyPatients 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 25 Gy in 5 fractions will be prescribed to the 90% isodose line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAlso: Radiation therapy25 Gy in 5 fractions | Radiation | Radiotherapy for patients with nonresectable keloids |
Primary outcome
Treatment-related toxicities
Time frame: Up to 1 year (+/- 1 month) post radiotherapy
The number of patients with treatment related toxicities will be determined by the incidence of grade 2 or higher skin-related adverse events based on CTCAE V5.0 criteria during prescheduled study visits. The number of patients with treatment related toxicities will be reported in aggregate for all visits.
10 secondary outcomes
Cessation of growth or shrinkage of keloids
Time frame: Week 0, during treatment (as close to the end of the radiotherapy course as practicable
Cessation of growth or shrinkage of keloids
Time frame: Up to 2 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
Time frame: Up to 6 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
Time frame: Up to 10 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
Time frame: Up to 6 months (+/- 1 month) post radiotherapy
Cessation of growth or shrinkage of keloids
Time frame: Up to 1 year (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Time frame: During treatment. Assessed as close to the end of the radiotherapy course as practicable, up to ~1 week
Quality of Life as determined by SKINDEX-16 questionnaire
Time frame: Up to 10 weeks (+/- 1 week) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Time frame: Up to 6 months (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Time frame: Up to 1 year (+/- 1 month) post radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 11316560Guix B, Henriquez I, Andres A, Finestres F, Tello JI, Martinez A. Treatment of keloids by high-dose-rate brachytherapy: A seven-year study. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):167-72. doi: 10.1016/s0360-3016(00)01563-7.
- Background: PubMed 28177974Mankowski P, Kanevsky J, Tomlinson J, Dyachenko A, Luc M. Optimizing Radiotherapy for Keloids: A Meta-Analysis Systematic Review Comparing Recurrence Rates Between Different Radiation Modalities. Ann Plast Surg. 2017 Apr;78(4):403-411. doi: 10.1097/SAP.0000000000000989.
- Background: PubMed 3182326Borok TL, Bray M, Sinclair I, Plafker J, LaBirth L, Rollins C. Role of ionizing irradiation for 393 keloids. Int J Radiat Oncol Biol Phys. 1988 Oct;15(4):865-70. doi: 10.1016/0360-3016(88)90119-8.
- Background: PubMed 29426811Bijlard E, Timman R, Verduijn GM, Niessen FB, Hovius SER, Mureau MAM. Intralesional cryotherapy versus excision with corticosteroid injections or brachytherapy for keloid treatment: Randomised controlled trials. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):847-856. doi: 10.1016/j.bjps.2018.01.033. Epub 2018 Feb 6.
- Background: PubMed 28979658Cheraghi N, Cognetta A Jr, Goldberg D. RADIATION THERAPY for the Adjunctive Treatment of Surgically Excised Keloids: A Review. J Clin Aesthet Dermatol. 2017 Aug;10(8):12-15. Epub 2017 Aug 1.
- Background: PubMed 29970316Renz P, Hasan S, Gresswell S, Hajjar RT, Trombetta M, Fontanesi J. Dose Effect in Adjuvant Radiation Therapy for the Treatment of Resected Keloids. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):149-154. doi: 10.1016/j.ijrobp.2018.05.027. Epub 2018 May 17.
- Background: PubMed 29799578Goutos I, Ogawa R. Brachytherapy in the adjuvant management of keloid scars: literature review. Scars Burn Heal. 2017 Nov 10;3:2059513117735483. doi: 10.1177/2059513117735483. eCollection 2017 Jan-Dec.
- Background: PubMed 25584136Rossi AM, Nehal KS, Lee EH. Radiation-induced Breast Telangiectasias Treated with the Pulsed Dye Laser. J Clin Aesthet Dermatol. 2014 Dec;7(12):34-7.
- Background: PubMed 15214654Malaker K, Vijayraghavan K, Hodson I, Al Yafi T. Retrospective analysis of treatment of unresectable keloids with primary radiation over 25 years. Clin Oncol (R Coll Radiol). 2004 Jun;16(4):290-8. doi: 10.1016/j.clon.2004.03.005.
- Background: PubMed 22984682Kim J, Lee SH. Therapeutic results and safety of postoperative radiotherapy for keloid after repeated Cesarean section in immediate postpartum period. Radiat Oncol J. 2012 Jun;30(2):49-52. doi: 10.3857/roj.2012.30.2.49. Epub 2012 Jun 30.
- Background: PubMed 2126387Lo TC, Seckel BR, Salzman FA, Wright KA. Single-dose electron beam irradiation in treatment and prevention of keloids and hypertrophic scars. Radiother Oncol. 1990 Nov;19(3):267-72. doi: 10.1016/0167-8140(90)90153-n.
- Background: PubMed 11443481Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10. doi: 10.1007/BF02737863. Epub 2001 Mar 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keyur J Mehta, MD principal investigator
Montefiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Keloid, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyur Mehta, MD (917-927-8244, kmehta@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related toxicities (time frame: Up to 1 year (+/- 1 month) post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722263, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.