Tracer Targeting FAP PET Imaging in Patients

NCT05691894 | Unknown Early Phase 1

• 1 other identifier: LS2020024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of tissue distribution of 18F-FAPI

  Biodistribution of 18F-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-PET scans will be reported.

  1 day

• Evaluation of tissue distribution of 68Ga-FAPI

  Biodistribution of 68Ga-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.

  1 day

Study Arms (2)

18F-FAPI

EXPERIMENTAL

Drug: 18F-FAPI

68Ga-FAPI

EXPERIMENTAL

Drug: 68Ga-FAPI

Interventions

18F-FAPI DRUG

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

18F-FAPI

68Ga-FAPI DRUG

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

68Ga-FAPI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, 214000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

68Ga-FAPI

Study Officials

• Chunjing Yu

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjing Yu

CONTACT

15312238622; ycj_wxd1978@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: November 2, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

CN (1)