This study is a single-center, open-label first-in-human clinical study. Patients with clinically suspected or confirmed malignant solid tumors will undergo \[68Ga\]Ga-FAP PET imaging or \[177Lu\]Lu-FAP SPECT imaging as well as \[18F\]FDG PET imaging to determine the presence or absence of lesions, and to assess lesion location, characteristics, and metastasis. Histopathological diagnosis or follow-up results will serve as the reference standard. The diagnostic efficacy of \[68Ga\]Ga-FAP PET imaging or \[177Lu\]Lu-FAP SPECT imaging for malignant tumors will be evaluated. Additionally, the study will analyze the biodistribution and dosimetry of \[177Lu\]Lu-FAP following a single administration, explore the correlation between tumor uptake values on imaging and immunohistochemical FAP expression levels, and evaluate the safety and tolerability of a single low-dose intravenous injection of \[68Ga\]Ga-FAP or \[177Lu\]Lu-FAP for diagnostic imaging.
Voluntary participation and the patient or their legal representative is able to sign an informed consent form.
Adult patients (aged 18 or above), regardless of gender.
Patients with an ECOG performance status of 0 to 1 and able to tolerate PET and SPECT/CT examinations.
Patients with histopathologically or clinically confirmed malignant solid tumors who have measurable lesions according to RECIST 1.1 criteria.
Patients who are pregnant or breastfeeding, or plan to become pregnant during the study period or within three months after study drug administration (excluding those who have been postmenopausal for at least one year, or those who are surgically sterilized, such as bilateral tubal ligation without recanalization, bilateral oophorectomy, or hysterectomy); or patients who plan to donate sperm or eggs during the study period or within three months after study drug administration.
Patients with known or suspected allergy to the investigational drug or any of its components, or patients with severe allergic constitution.
Patients who have undergone procedures within 6 months prior to study entry that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion.
Patients with positive syphilis or HIV test results at screening.