An Early Phase 1 interventional study of Novel FAP-targeted probe in Malignant Neoplasm, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Early Phase 1, Interventional, and Diagnostic
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 160 studies on the registry; 129 are open to participants now.
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This project aims to perform integrated SPECT/CT or PET/MR imaging in patients with histologically confirmed malignant neoplasms with high fibroblast activation protein (FAP) expression. This study utilizes a FAP-specific PET/SPECT imaging probe to evaluate the feasibility, accuracy, and clinical value in malignant neoplasm.
Drug: Novel FAP-targeted probe
For Cancer patients, subjects should have targeting FAP scans
Visual and standardized uptake values assessment of lesions and biodistribution
At least two experienced nuclear medicine physicians will analyze the images, using histopathological diagnosis or follow-up findings as the reference standard.The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case.
Time frame: 1 month
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology