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

NCT ID: NCT06684028

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2025-07-31

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.

Conditions

Cancer; Solid Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

68Ga-FAPI-JNU

Intervention Type: DRUG

Patients will receive the novel tracer 68Ga-FAPI-JNU dose of approximately 2-5 mCi per person

Interventions

68Ga-FAPI-JNU

Patients will receive the novel tracer 68Ga-FAPI-JNU dose of approximately 2-5 mCi per person

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: lead

Responsible Party

Chunjing Yu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

chunjing Yu

Role: CONTACT

ycj_wxd1978@163.com

15312238622

Facility Contacts

Chunjing Yu

Role: primary

ycjwxd1978@jiangnan.edu.cn

15312238622

Other Identifiers

LS2024013

Identifier Type: -

Identifier Source: org_study_id