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

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.

Recruiting

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Key information

Conditions

Pancreatic Cancer Astrocytoma Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Glioblastoma Glioma Head and Neck Neoplasms Head and Neck Tumors Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan Union Hospital, China

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Xiaoli Lan, PhD

CONTACT

[email protected]

+86-027-83692633

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Each subject must meet all of the following inclusion criteria to be eligible for study enrollment:

The subject or their legally authorized representative (LAR) is capable of providing a signed and dated informed consent form (ICF);
Willing and able to comply with all study procedures and cooperate throughout the entire duration of the study;
Adult patients or healthy volunteers, aged 18 years or older, male or female;
Patients with clinically suspected or confirmed malignancies (supported by evidence such as relevant serum tumor markers, imaging modalities including ultrasound, CT, and MRI, or histopathological examinations) who are in good general condition;
Women of childbearing potential (WOCBP) must have used effective contraception for at least one month prior to screening and agree to continue contraceptive use throughout the study period and for a specified duration following study completion;
Must meet any other protocol-specified inclusion criteria.

Exclusion criteria

Any subject meeting any of the following baseline criteria will be excluded from the study:

Inability to tolerate or complete PET/MR or PET/CT examinations (including, but not limited to, the inability to lie supine, claustrophobia, radiophobia, etc.);
Presence of other comorbidities, such as acute systemic illnesses and electrolyte imbalances;
Known allergy or hypersensitivity to the LRRC15 radiotracer or its synthetic excipients; fasting blood glucose level exceeding 11.0 mmol/L prior to [¹⁸F]FDG injection;
Patients deemed by the investigator to have poor expected compliance;
Pregnant or lactating (nursing) women;
Presence of any other conditions or factors that, in the opinion of the investigator, would make the subject unsuitable for participation in this trial.

Treatment and study plan

Specific PET imaging agents targeting LRRC15

Diagnostic Test

Primary outcomes

Visual and standardized uptake values assessment of lesions and biodistribution

Time frame: 1 year

At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of the tumor and organs will be measured after a semiquantitative analysis is performed for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting LRRC15 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or a higher stage.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Lan, PhD

CONTACT

[email protected]

0086-027-83692633

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 27, 2026
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed