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

ConditionsPancreatic Cancer Breast Cancer Lung Cancer Sarcoma Head and Neck Tumors Glioblastoma Colorectal Cancer Melanoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

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

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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.

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

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