## Protocol Section
### Identification Module
**NCT ID:** NCT06431360

**Brief Title:** Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid

**Official Title:** Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid

#### Organization Study ID Info
**ID:** KY20240514-02
#### Organization
**Class:** OTHER
**Full Name:** Nanjing First Hospital, Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nanjing First Hospital, Nanjing Medical University

#### Responsible Party

**Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University

**Investigator Full Name:** Feng Wang

**Investigator Title:** Director of nuclear medicine department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Keloid

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sr-90 brachytherapy followed by hyperthermia.

**Intervention Names:**

- Other: hyperthermia

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Sr-90 brachytherapy alone.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

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

**Name:** hyperthermia

**Other Names:**

- heater

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

comparable anatomic location.

**Measure:** Patient and Observer Scar Assessment Scale (POSAS) scores

**Time Frame:** once every 3 months for 1 year after the last treatment

**Description:** Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple).

**Measure:** Vancouver Scar Scale (VSS) scores

**Time Frame:** once every 3 months for 1 year after the last treatment

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 75 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fengwangcn@hotmail.com

**Name:** Feng Wang

**Phone:** 86-025-52271455

**Role:** CONTACT

**Contact 2:**

**Email:** liangshi@njmu.edu.cn

**Name:** Liang Shi

**Phone:** 86-025-52271491

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Email:** fengwangcn@hotmail.com

- **Name:** Feng Wang, Ph.D.

- **Phone:** 86-025-52271455

- **Role:** CONTACT

**Country:** China

**Facility:** Nanjing First Hospital

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 210006

**Location 2:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Email:** fengwangcn@hotmail.com

- **Name:** Feng Wang

- **Phone:** 86-025-52271455

- **Role:** CONTACT

***Contact 2:***

- **Email:** liangshi@njmu.edu.cn

- **Name:** Liang Shi

- **Phone:** 86-025-52271491

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Nanjing Medical Univerity

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 210006

#### Overall Officials

**Official 1:**

**Affiliation:** Nanjing First Hospital, Nanjing Medical University

**Name:** Feng Wang

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001832

- Term: Body Temperature Changes

- ID: D000018882

- Term: Heat Stress Disorders

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000003095

- Term: Collagen Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000002921

- Term: Cicatrix

- ID: D000005355

- Term: Fibrosis

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M10654

- Name: Keloid

- Relevance: HIGH

- As Found: Keloid

- ID: M2454

- Name: Hyperthermia

- Relevance: HIGH

- As Found: Hyperthermia

- ID: M8464

- Name: Fever

- Relevance: LOW

- As Found: Unknown

- ID: M5111

- Name: Body Temperature Changes

- Relevance: LOW

- As Found: Unknown

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M20924

- Name: Heat Stress Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007627

- Term: Keloid

- ID: D000084462

- Term: Hyperthermia

### Misc Info Module

- Version Holder: 2024-05-31
