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

NCT07552467 | Recruiting

• 1 other identifier: XLan-260401
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer; Breast Cancer; Lung Cancer; Sarcoma; Head and Neck Tumors; Glioblastoma; Colorectal Cancer; Melanoma

Outcome Measures

Primary Outcomes (1)

• Visual and standardized uptake values assessment of lesions and biodistribution

  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.

  1 year

Interventions

Specific PET imaging agents targeting LRRC15 DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinically suspected or confirmed malignancies-such as pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma (supported by evidence including serum tumor markers, ultrasound, CT, MRI, and tissue histopathological examinations)-who are in good general condition.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital, China

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Breast Neoplasms; Lung Neoplasms; Sarcoma; Head and Neck Neoplasms; Glioblastoma; Colorectal Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaoli Lan, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-03

Locations

CN (1)