A Novel 68Ga Labeled FAP Ligand PET/CT in Patients With Various Malignant Tumors

NCT06186427 | Unknown DMC

• 1 other identifier: 68Ga-DOTA-GPFAPI-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed and synthesized a novel fibroblast activation protein (FAP) ligand (DOTA-GPFAPI-04) by assembling three functional moieties: a quinoline-based FAP inhibitor for specifically targeting FAP, a FAP substrate Gly-Pro as a linker for increasing the FAP protein interaction, and a 2,2',2",2‴-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl)tetraacetic acid (DOTA) chelator for radiolabeling with different radionuclides. Molecular docking studies investigated the FAP targeting ability of DOTA-GPFAPI-04. DOTA-GPFAPI-04 was then radiolabeled with 68Ga to give 68Ga-DOTA-GPFAPI-04 for positron emission tomography (PET) imaging. The investigators found that the 68Ga-DOTA-GPFAPI-04 has high stability, targeted specificity, and longer retention time. The tumor-to-muscle (T/M) ratio for 68Ga-DOTA-GPFAPI-04 reached 9.15.

Conditions

Cancer; Malignant Neoplasm; Tumors; Metastatic Cancer

Keywords

Fibroblast Activation Protein Targeting Probe; PET/CT; PET/MRI

Outcome Measures

Primary Outcomes (1)

• SUVmax (Standardized Uptake Value max)

  Manual delineation of the area of interest to measure the maximum standard uptake values of the primary lesion and each metastatic lesion

  Within 24 hours after the patient's PET/CT scan is completed

Secondary Outcomes (1)

• Tumor-to-background ratios

  Within 24 hours after the patient's PET/CT scan is completed

Study Arms (1)

68Ga-DOTA-GPFAPI-04 PET/CT

EXPERIMENTAL

Imaging was performed 60 minutes after injection of 5mci 68Ga-DOTA-GPFAPI-04 tracer

Diagnostic Test: 68Ga-DOTA-GPFAPI-04 PET/CT

Interventions

68Ga-DOTA-GPFAPI-04 PET/CT DIAGNOSTIC_TEST

The same group of patients underwent 68Ga-DOTA-GPFAPI-04 PET/CT and FDG PET/CT examinations respectively

Also known as: FDG PET/CT examinations

68Ga-DOTA-GPFAPI-04 PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with high clinical suspicion of malignant tumors;
• Those who have undergone endoscopic biopsy or puncture biopsy indicating malignant tumors but have not undergone surgery or chemotherapy;
• Previous history of malignant tumor surgery, suspected of recurrence or distant metastasis;
• There is a willingness for puncture biopsy or surgery, and there are no contraindications for puncture biopsy or surgery, and there are no contraindications for anesthesia;
• Sign an informed consent form and undergo a nuclear medicine examination, without any contraindications, with the ability and willingness to participate in the follow-up plan.

You may not qualify if:

• Those who cannot tolerate puncture biopsy or surgical contraindications;
• Those who have undergone radiotherapy and chemotherapy in the past 3 months;
• Individuals who are allergic to multiple drugs or foods;
• Those who refuse nuclear medicine examinations;
• Those who do not agree to sign an informed consent form and are unable or willing to follow up.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Shanghai Institute of Materia Medica, Chinese Academy of Sciences: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (3)

• Pang Y, Zhao L, Fang J, Chen J, Meng L, Sun L, Wu H, Guo Z, Lin Q, Chen H. Development of FAPI Tetramers to Improve Tumor Uptake and Efficacy of FAPI Radioligand Therapy. J Nucl Med. 2023 Sep;64(9):1449-1455. doi: 10.2967/jnumed.123.265599. Epub 2023 Jun 15.

  PMID: 37321827 RESULT

• Zhao L, Niu B, Fang J, Pang Y, Li S, Xie C, Sun L, Zhang X, Guo Z, Lin Q, Chen H. Synthesis, Preclinical Evaluation, and a Pilot Clinical PET Imaging Study of 68Ga-Labeled FAPI Dimer. J Nucl Med. 2022 Jun;63(6):862-868. doi: 10.2967/jnumed.121.263016. Epub 2021 Sep 23.

  PMID: 34556528 RESULT

• Lai C, Cao R, Li R, He C, Wang X, Shi H, Qu C, Qian K, Song S, Chen WH, Cheng Z. Fibroblast Activation Protein Targeting Probe with Gly-Pro Sequence for PET of Glioblastoma. Mol Pharm. 2023 Aug 7;20(8):4120-4128. doi: 10.1021/acs.molpharmaceut.3c00248. Epub 2023 Jul 24.

  PMID: 37487027 RESULT

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: January 13, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 2 years after the completion of the study
• Access Criteria: Case Record Form and Electronic Collection and Management System

Locations

CN (1)