LRRC15-targeted PET imaging for more precise diagnosis and staging of pancreatic, breast, lung, sarcoma and head-and-neck cancers

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 tests whether an LRRC15-targeted PET scan can better detect and stage LRRC15-expressing cancers and measures how the tracer behaves in healthy adults.

Quick facts

• Study type: Observational
• Enrollment: 26 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07552467 on ClinicalTrials.gov

What this trial studies

This observational project uses LRRC15-specific PET radiotracers with PET/MR or PET/CT in healthy volunteers and patients with suspected or confirmed LRRC15-expressing malignancies, including pancreatic, breast, lung, sarcoma, head and neck tumors (and other tumor types listed). Imaging results will be compared with histopathology as the diagnostic gold standard and with conventional PET tracers such as [18F]FDG or [68Ga]Ga-FAPI to define diagnostic accuracy, lesion detection, anatomical localization, staging, and tumor burden. Healthy volunteers will undergo pharmacokinetic analyses to characterize tracer distribution, clearance, and safety. All imaging and comparisons are conducted at Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Who should consider this trial

Good fit: Adults (18+) with clinically suspected or confirmed malignancies supported by imaging, biomarkers, or histopathology—particularly cancers known or suspected to express LRRC15 such as pancreatic, breast, lung, sarcoma, and head-and-neck cancers—or healthy adults for tracer pharmacokinetic study are ideal candidates.

Not a fit: Patients whose tumors do not express LRRC15 or who cannot undergo PET imaging (for example due to inability to travel to the site or contraindications to PET procedures) are unlikely to benefit from this imaging approach.

Why it matters

Potential benefit: If successful, LRRC15-targeted PET could improve detection and staging of LRRC15-expressing tumors and help clinicians make more informed treatment decisions.

How similar studies have performed: LRRC15-targeted imaging is a relatively novel approach with limited early clinical and preclinical data, while comparative tracers like [18F]FDG and [68Ga]Ga-FAPI are better established.

Eligibility criteria

Inclusion Criteria:

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

1. The subject or their legally authorized representative (LAR) is capable of providing a signed and dated informed consent form (ICF);
2. Willing and able to comply with all study procedures and cooperate throughout the entire duration of the study;
3. Adult patients or healthy volunteers, aged 18 years or older, male or female;
4. 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;
5. 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;
6. 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:

1. Inability to tolerate or complete PET/MR or PET/CT examinations (including, but not limited to, the inability to lie supine, claustrophobia, radiophobia, etc.);
2. Presence of other comorbidities, such as acute systemic illnesses and electrolyte imbalances;
3. 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;
4. Patients deemed by the investigator to have poor expected compliance;
5. Pregnant or lactating (nursing) women;
6. Presence of any other conditions or factors that, in the opinion of the investigator, would make the subject unsuitable for participation in this trial.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital, China — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaoli Lan, PhD

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