Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid

NCT ID: NCT06431360

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2025-06-30

Brief Summary

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Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .

Detailed Description

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Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min

Conditions

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Keloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Sr-90 brachytherapy followed by hyperthermia.

Group Type EXPERIMENTAL

hyperthermia

Intervention Type OTHER

hyperthermia (using a heater, 44℃for 15 min)

Control group

Sr-90 brachytherapy alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hyperthermia

hyperthermia (using a heater, 44℃for 15 min)

Intervention Type OTHER

Other Intervention Names

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heater

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Feng Wang

Director of nuclear medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Wang

Role: STUDY_DIRECTOR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanjing Medical Univerity

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Wang

Role: CONTACT

86-025-52271455

Liang Shi

Role: CONTACT

86-025-52271491

Facility Contacts

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Feng Wang, Ph.D.

Role: primary

86-025-52271455

Feng Wang

Role: primary

86-025-52271455

Liang Shi

Role: backup

86-025-52271491

Other Identifiers

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KY20240514-02

Identifier Type: -

Identifier Source: org_study_id

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