The Clinical Application Value of SPECT Imaging Targeting LRRC15 in Malignant Tumors

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"This project involves patients with high-expression LRRC15 malignant tumors who are either clinically suspected of or diagnosed with pancreatic cancer, breast cancer, lung cancer, ovarian cancer, head and neck tumors, colorectal cancer, melanoma, etc., as well as healthy volunteers. Using a targeted LRRC15-specific SPECT imaging agent, SPECT/CT imaging is performed to achieve the following objectives:

For malignant tumor patients:

To support disease diagnosis and staging. Diagnostic performance will be evaluated against the gold standard of pathological diagnosis, clarifying the presence or absence of lesions and determining their location and nature.

To enable accurate staging and assess tumor burden by comparison with [18F]FDG PET/CT, thereby aiding in the determination of treatment plans.

For healthy volunteers:

To conduct pharmacokinetic analysis, elucidating the distribution, metabolism, and safety profile of the agent in the body."

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Key information

Conditions

Pancreatic Cancer Adnexal Diseases 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 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Glioma Gonadal Disorders Head and Neck Cancers Head and Neck Neoplasms 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 Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan Union Hospital, China

Wuhan, Hubei, 430030, China

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 SPECT/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 SPECT imaging agents targeting LRRC15

Diagnostic Test

This project utilizes LRRC15-specific targeted SPECT radiotracers to perform SPECT/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.

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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 16, 2026
Registry last updated: Jun 16, 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.

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Completed