NCT07660406

Brief Summary

Keloids are often described as benign dermal fibroproliferative lesions characterized by increased growth beyond the boundaries of the original wound margin.Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-RGD PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
15mo left

Started Aug 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Aug 2024Oct 2027

First Submitted

Initial submission to the registry

June 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

June 22, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

June 28, 2024

Last Update Submit

June 17, 2026

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

  • Correlation with clinical symptoms, laboratory tests

    The clinical assessment of keloids commonly includes the Vancouver Scar Scale for objective scar evaluation, along with laboratory inflammatory markers such as complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP).

    1 year

Study Arms (1)

68Ga-RGD PET/CT

EXPERIMENTAL

All patients diagnosed with keloid underwent 68Ga-RGD PET/CT.

Drug: 68Ga-RGD

Interventions

68Ga-RGDDRUG

Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga- FAPI will be used to image lesions of keloid by PET/ CT.

68Ga-RGD PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients with a clinical diagnosis of keloids Able to obtain informed consent

You may not qualify if:

  • \- Pregnant women, children, patients with allergies to contrast media Patients with claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

1361109375213611093752@163.com

Jiarou Wang, MD

CONTACT

13628477019ChristinaWang97@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

June 22, 2026

Study Start

August 1, 2024

Primary Completion

October 23, 2024

Study Completion (Estimated)

October 1, 2027

Last Updated

June 22, 2026

Record last verified: 2026-03

Locations

CN(1)