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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-21

Study Completion Date

2022-11-25

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Cancer

Keywords

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FAPI dimer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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68Ga-FAPI dimer(68Ga-LNC1013)

68Ga-LNC1013 was evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuo Hu, Dr

Role: STUDY_CHAIR

Xiangya Hospital, Central South University, Changsha, P.R. China

Locations

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Jian Li

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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PETcenter

Identifier Type: -

Identifier Source: org_study_id