PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors

Not Applicable

Recruiting

• Conditions: Cancer; Solid Malignancies
• Interventions: Drug: 68Ga-FAPI-JNU

• Registration Number: NCT06684028
• Lead Sponsor: Affiliated Hospital of Jiangnan University

Brief Summary

To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.

Detailed Description

PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.

Study Timeline

• Study Start: 2023-07-12
• Status Verified: 2024-11
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-10
• Study First Posted: 2024-11-12
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
2. Age 18-85 years old, male or female;
3. Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
4. ECOG score is 0-3 points;

Exclusion Criteria

1. Patients with a history or allergic constitution to any component of the developer, including alcohol;
2. pregnant or lactating women;
3. Patients with mental illness or related history;
4. Patients who cannot or cannot undergo a PET/CT scan;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-JNU	68Ga-FAPI-JNU	68Ga-FAPI-JNU is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 hour after injection

Primary Outcome Measures

Name	Time	Method
Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues	4 hour	CT and PET scans were performed on the patients injected with 68Ga-FAPI-JNU. After image reconstruction and PET/CT image fusion, the biological distribution of 68Ga-FAPI-JNU in the primary tumor, metastatic tumor and various tissues and organs of the patients was evaluated by radioactive uptake value (standardized uptake value, SUV)

Trial Locations

Locations (1)

Affiated Hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China