Tracer Targeting FAP PET Imaging in Patients

Affiliated Hospital of Jiangnan University

Status and phase: Enrolling; Early Phase 1

Conditions: Cancer

Treatments: Drug: 18F-FAPI; Drug: 68Ga-FAPI

Study type: Interventional

Funder types: Other

Identifiers

NCT05691894

LS2020024

Details and patient eligibility

About

This is a single arm study to evaluate the safety and biodistribution of tracer targeting FAP PET Imaging in patients

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0~2.

Exclusion criteria

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

18F-FAPI

Experimental group

Treatment:

Drug: 18F-FAPI

68Ga-FAPI

Experimental group

Treatment:

Drug: 68Ga-FAPI