Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2022-01-04
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-Anti-PSMA mAbs
68Ga-labeled NY108
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.
Interventions
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68Ga-labeled NY108
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.
Eligibility Criteria
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Inclusion Criteria
2. Age 18-75, male;
3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. Patients with biopsy-proven PSMA positive;
6. ECOG score 0\~3; Life expectancy of at least 3 months;
Exclusion Criteria
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation;
7. Uncontrolled hypertension;
8. Syphilis, HBV, HCV, or HIV positive subjects;
9. Male subjects of reproductive age cannot take effective contraceptive measures;
10. Patients with a history of mental illness or related conditions;
11. Other subjects considered unsuitable by researchers.
18 Years
75 Years
MALE
No
Sponsors
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Affiliated Hospital of Jiangnan University
OTHER
Responsible Party
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Chunjing Yu
Director
Principal Investigators
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Chunjing Yu
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Jiangnan University
Locations
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Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fu H, Lou K, He H, Wang Y, Mi Y, Li W, Chen L, Zhang Y, Yu C. A novel PSMA targeted dual-function near-infrared fluorescence and PET probe for the image-guided surgery and detection of prostate cancer. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):2998-3008. doi: 10.1007/s00259-023-06492-x. Epub 2023 Nov 2.
Other Identifiers
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LS2020005
Identifier Type: -
Identifier Source: org_study_id
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