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Urokinase plasminogen activator receptor (uPAR), the cell-surface receptor for its ligand uPA, plays a critical role in regulating cell migration and invasion-key drivers of cancer progression. This study aims to evaluate a novel uPAR-targeting radiopharmaceutical pair: the diagnostic agent [⁶⁸Ga]Ga-HT547 and the therapeutic agent [¹⁷⁷Lu]Lu-HT547. In patients with breast cancer, head and neck cancer, pancreatic cancer, or glioma, we will assess the diagnostic performance and biodistribution of these tracers using [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 SPECT/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancers group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 | Drug | All enrolled participants will undergo the same intervention procedure: first, a single intravenous dose (approximately 150 MBq) of ⁶⁸Ga-HT547 for uPAR-targeted PET/CT diagnostic imaging. Subsequently, a single intravenous dose (approximately 4 GBq) of ¹⁷⁷Lu-HT547 will be administered for follow-up SPECT/CT imaging and dosimetry studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy | To assess the diagnostic feasibility of uPAR-targeted imaging, including: 1) Tumor uptake intensity (SUVmax, SUVmean) and target-to-background ratios (TBR) on ⁶⁸Ga-HT547 PET/CT; 2) Human radiation dosimetry of ¹⁷⁷Lu-HT547 based on SPECT/CT biodistribution data, estimating organ absorbed doses and effective whole-body dose. | Screening, Day 1 post-⁶⁸Ga-HT547, Day 1, 3, 5, 7 post-¹⁷⁷Lu-HT547 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.
History of severe allergic reaction to any component of the investigational drug injection.
Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.
Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.
Received any investigational drug within 28 days prior to the first dose, or concurrent participation in another clinical study (except: participation in an observational, non-interventional study, or being in the follow-up phase of an interventional study).
History of other known malignancies within the past 5 years.
Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
Inadequate organ function (meeting any of the following):
Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including:
Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose.
Major surgery or significant trauma within 28 days prior to the first dose.
Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation.
Inability of the subject to understand and comply with study instructions and requirements.
Any other situation deemed inappropriate by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Pang, Doctor | Contact | +8615923039337 | phua1973@163.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D005910 | Glioma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| D004067 |
| Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |