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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06159049
• Other study ID #: PETcenter
• Status: Completed
• Start date: July 21, 2022
• Est. completion date: November 25, 2022

Study information

• Verified date: September 2023
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 25, 2022
• Est. primary completion date: July 21, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Diagnostic Test:
• 68Ga-FAPI dimer(68Ga-LNC1013)
68Ga-LNC1013 was evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Locations

Country	Name	City	State
China	Jian Li	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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