68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage
NCT ID: NCT04158817
Last Updated: 2023-04-18
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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COMPLETED
EARLY_PHASE1
8 participants
INTERVENTIONAL
2019-11-01
2023-03-31
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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Experimental Arm
All Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection.
68Ga-Labeled PSMA
All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.
Non-labeled PSMA
Patient will be injected with microdose (\<100 ug) of THP-PSMA
Interventions
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68Ga-Labeled PSMA
All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.
Non-labeled PSMA
Patient will be injected with microdose (\<100 ug) of THP-PSMA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prior diagnosis of prostatic cancer
3. Willing to participate in this study and given written informed consent
4. AST, ALT, BUN, Cr not more than double the normal values
5. Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment
Exclusion Criteria
2. Hepatitis B virus infection (including carriers) at screening, i.e. hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
3. Abnormal liver function during baseline screening period: AST or ALT\> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if more than 2 times ULN after retesting, consider enrolling).
4. Impaired renal function during screening: serum creatinine or urea nitrogen \> 1.5 times ULN.
5. Within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
6. Subjects with pulmonary embolism or deep vein thrombosis
7. Various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections.
8. Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)
18 Years
79 Years
MALE
No
Sponsors
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NanoMab Technology (UK) Limited
INDUSTRY
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Zhao Jin Hua, MD
Director Department of Nuclear Medicine, Principal Investigator, Professor
Principal Investigators
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Jinhua Zhao, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Nuclear Medicine, Shanghai General Hospital
Locations
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Shanghai General Hospital
Shanghai, , China
Countries
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Other Identifiers
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[2018]15
Identifier Type: -
Identifier Source: org_study_id
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