Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07552467

Sub-topic Four: Clinical Translation of Original Radioactive Drugs for Precision Diagnosis and Treatment of Gastrointestinal Tumors -Clinical Application Value of PET Imaging Targeting LRRC15 in Malignant Tumors

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-04-27

26

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This project utilizes LRRC15-specific targeted PET radiotracers to perform PET/MR or PET/CT imaging on healthy volunteers and patients with clinically suspected or confirmed malignancies characterized by high LRRC15 expression-including pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma. The study aims to achieve the following objectives: For patients with malignant tumors: To diagnose and stage the disease. By comparing the imaging results against the gold standard of histopathological diagnosis, the study aims to evaluate diagnostic efficacy, ascertain the presence or absence of lesions, and characterize their anatomical location and nature. Furthermore, through comparison with \[¹⁸F\]FDG PET or \[⁶⁸Ga\]Ga-FAPI PET, the study seeks to achieve accurate disease staging, assess tumor burden, and facilitate therapeutic decision-making. For healthy volunteers: To conduct pharmacokinetic analyses to determine the in vivo biodistribution and metabolic patterns of the radiotracer, as well as to evaluate its safety profile.

CONDITIONS

Official Title

Sub-topic Four: Clinical Translation of Original Radioactive Drugs for Precision Diagnosis and Treatment of Gastrointestinal Tumors -Clinical Application Value of PET Imaging Targeting LRRC15 in Malignant Tumors

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed and dated informed consent
  • Willing and able to follow all study procedures and cooperate throughout the study
  • Adults aged 18 years or older, any gender
  • Patients with suspected or confirmed malignancies supported by tumor markers, imaging, or pathology, in good general condition
  • Women of childbearing potential must use effective contraception for at least one month before screening and during and after the study
  • Must meet any other protocol-specified inclusion criteria
Not Eligible

You will not qualify if you...

  • Unable to tolerate or complete PET/MR or PET/CT scans (e.g., cannot lie supine, claustrophobia, radiophobia)
  • Have acute systemic illnesses or electrolyte imbalances
  • Known allergy or hypersensitivity to LRRC15 radiotracer or excipients; fasting blood glucose over 11.0 mmol/L before 18F-FDG injection
  • Poor expected compliance as judged by investigator
  • Pregnant or breastfeeding women
  • Any other condition that makes the participant unsuitable as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wuhan Union Hospital, China

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

X

Xiaoli Lan, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Sub-topic Four: Clinical Translation of Original Radioactive Drugs for Precision Diagnosis and Treatment of Gastrointestinal Tumors -Clinical Application Value of PET Imaging Targeting LRRC15 in Malignant Tumors | DecenTrialz