Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013

Completed

• Conditions: Gastrointestinal Cancer

• Registration Number: NCT06159049
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

Fibroblast activation protein (FAP) emerges as a highly promising target for cancer diagnostic imaging and targeted radionuclide therapy. To exploit the therapeutic potential of current FAP inhibitors (FAPIs), this study presented the design and synthesis of a series of FAPI dimers to increase tumor uptake and retention. Preclinical evaluation and a pilot clinical PET imaging study were conducted to screen the lead compound with the potential for radionuclide therapy.

Detailed Description

Three new FAPI dimers were synthesized by linking two quinoline-based FAPIs with different spacers. The in vitro binding affinity and preclinical small animal PET imaging of the compounds were compared with their monomeric counterparts, FAPI-04 and FAPI-46. The lead compound, 68Ga-LNC1013, was then evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Study Timeline

• Study Start: 2022-07-21
• Primary Completion: 2022-07-21
• Study Completion: 2022-11-25
• Status Verified: 2023-09
• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Histologically and/or clinically confirmed and/or suspicious of gastrointestinal cancer.
2. Signed informed consent.

Exclusion Criteria

1. pregnancy;
2. breastfeeding;
3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)	5 months	Comparison of 68Ga\]Ga-LNC1013, 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases
Number of discrepancies between [68Ga]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG PET scans	5 months	Compare the diagnostic performance between \[68Ga\]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG in patients with gastrointestinal cancer

Trial Locations

Locations (1)

Jian Li; 🇨🇳 Changsha, Hunan, China