Treatment of keloids using Strontium-90 brachytherapy and hyperthermia
Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
This study is testing if combining Strontium-90 treatment with heat therapy can help people with keloids get better results than just using Strontium-90 alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06431360 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Strontium-90 (Sr-90) brachytherapy combined with hyperthermia in treating keloids. Patients diagnosed with keloids are randomized into two groups: one receiving Sr-90 brachytherapy followed by hyperthermia, and the other receiving only Sr-90 brachytherapy. The treatment involves administering 6-7 Gy of Sr-90 twice a week for three weeks, with hyperthermia applied at 44℃ for 15 minutes. The goal is to assess whether the combination therapy yields better outcomes than brachytherapy alone.
Who should consider this trial
Good fit: Ideal candidates are individuals with clinically diagnosed keloids that are clean and have a thickness of 2-5mm and a diameter of at least 10mm.
Not a fit: Patients with cicatricial constitution, abnormal coagulation function, or those who have previously received adequate radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients suffering from keloids.
How similar studies have performed: While the combination of brachytherapy and hyperthermia is a novel approach, there may be limited prior studies specifically targeting keloids with this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation； * Body surface keloid thickness: 2\~5mm, diameter ≥10mm. Exclusion Criteria: * Women who plan to become pregnant within 3 months or are pregnant or breastfeeding; * Patients with cicatricial constitution; * Abnormal coagulation function; * Patients who have received an adequate dose or course of radiation therapy; * People with previous immune system diseases, diabetes and other metabolic diseases.
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Nanjing Medical Univerity — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Feng Wang
- Email: fengwangcn@hotmail.com
- Phone: 86-025-52271455
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.