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Clinical study evaluating the safety and imaging performance of 68Ga-NRT6020 injection for PET/CT imaging in patients with malignant solid tumors

Clinical study evaluating the safety and imaging performance of 68Ga-NRT6020 injection for PET/CT imaging in patients with malignant solid tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093835
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-12-15
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects diagnosed with malignant solid tumors through pathological diagnosis or highly suspected on imaging

Interventions

NRT6020:68Ga-NRT6020

Sponsors

Guilin Medical College Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Having the ability to act and voluntarily participating in this clinical study, and signing written informed consent before implementing any trial related procedures; 2.Age >= 18 years old; 3.Confirmed by pathological diagnosis or highly suspected by imaging as malignant solid tumor; 4.ECOG score 0-1 points; 5.Having sufficient organ function((1) Routine (not receiving infusion or colony stimulating factor (G-CSF) treatment within 14 days before signing the informed consent form): absolute neutrophil count >= 1.0 * 10 ^ 9/L, platelet count >= 50 * 10 ^ 9/L, hemoglobin = 80g/L; (2) Liver function: Total bilirubin (TBIL) 30 g/L; (3) Renal function: creatinine (Cr) = 50 mL/min (calculated according to the Cockcroft Gault formula); (4) Coagulation function: International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) <= 1.5 × ULN. If the subject is taking warfarin or heparin for anticoagulant therapy, it is necessary to confirm that the protocol requirements are met when stopping or not taking the medication); 6.Women and men of childbearing age must agree to take strict and effective contraceptive measures within 6 months after signing informed consent, during the study period, and after the end of the trial. Men are prohibited from donating sperm during this period, and women are prohibited from freezing eggs during this period. Female subjects of childbearing age must have a negative pregnancy test result within 3 days prior to the first administration.

Exclusion criteria

Exclusion criteria: 1.Subjects with NYHA heart function level 3 or 4; 2.Severe bleeding (such as gastrointestinal bleeding, intracranial bleeding) occurred within 6 months prior to the use of the investigational drug; 3.Individuals known to have severe allergies to drugs such as 68Ga FAP, ethanol, or other excipients; 4.Major surgery is defined as any surgical procedure involving general anesthesia and major incisions (i.e., incisions larger than those required for central venous access, percutaneous feeding tube, or biopsy) performed within 28 days prior to the patient signing the informed consent form; 5.Simultaneously suffering from two or more malignant tumors; 6.There are bacterial, viral, or fungal infections that require systemic treatment; 7.Accompanied by actively treated but still uncontrolled stable diseases, and judged by researchers to potentially affect the safety or efficacy of the investigational drug; 8.Individuals who have participated in any other interventional clinical trials within the past 3 months prior to screening (excluding those who have only participated in the screening of this clinical trial and have not used the investigational drug); 9.Pregnant or lactating women; 10.Any other researcher who determines that it is not suitable for inclusion in this study;

Design outcomes

Primary

MeasureTime frame
tumor SUVmax;

Countries

China

Contacts

Public ContactFu Wei

Guilin Medical College Affiliated Hospital

13977385850@126.com+86 13977385850

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026