Tracer Targeting FAP PET Imaging in Patients

Early Phase 1

Recruiting

• Conditions: Cancer
• Interventions: Drug: 68Ga-FAPI; Drug: 18F-FAPI

• Registration Number: NCT05691894
• Lead Sponsor: Affiliated Hospital of Jiangnan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-02
• Status Verified: 2023-01
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI	68Ga-FAPI	-
18F-FAPI	18F-FAPI	-

Primary Outcome Measures

Name	Time	Method
Evaluation of tissue distribution of 18F-FAPI	1 day	Biodistribution of 18F-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-PET scans will be reported.
Evaluation of tissue distribution of 68Ga-FAPI	1 day	Biodistribution of 68Ga-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.

Trial Locations

Locations (1)

Affiliated Hospital of Jiangnan University; 🇨🇳 Wuxi, China