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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wuhan Union Hospital, China
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xiaoli Lan, PhD
• Email: lxl730724@hotmail.com
• Phone: 0086-027-83692633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.