Tracer Targeting FAP PET Imaging in Patients

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05691894

Enrollment

Registered

2023-01-20

Start date

2022-11-02

Completion date

2023-11-30

Last updated

2023-01-20

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

Conditions

Cancer

Brief summary

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

Interventions

DRUG18F-FAPI

Patients will receive a tracer dose of 18F (8-10mCi) labelled FAPI

DRUG68Ga-FAPI

Patients will receive a tracer dose of 68Ga (2-5mCi) labelled FAPI

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactChunjing Yu

ycj_wxd1978@163.com15312238622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026