Clinical Study of Trap (FAPI) 3 PET Imaging in Noninvasive Diagnosis of Malignant Tumors

NCT07128277 | Not Yet Recruiting

• 1 other identifier: 2025179
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Positron Emission Tomography (PET) is a functional imaging technology for diagnosing and monitoring tumors. In clinical applications for malignant tumors, PET includes staging, response assessment, and prognosis prediction, providing attractive semi-quantitative biomarkers for both clinical and research platforms. Understanding the fundamentals of imaging science and evaluating the strengths and limitations of imaging modalities is crucial for optimizing research assessments. With the widespread use of functional techniques and the development of novel PET biomarkers, PET-based research evaluations will be further enhanced. The field of oncology has undergone a revolution through molecular imaging, which evaluates tumor biology, while traditional radiological imaging focuses on morphological anatomy . Molecular imaging employs non-invasive visualization at cellular or subcellular levels to observe physiological or pathological processes, whereas PET/CT serves as a hybrid imaging tool that provides complementary information on both function and structure . \[18F\] Fluorodeoxyglucose (FDG), first developed in the late 1970s as a tracer for brain region metabolism, remains the most widely used PET tracer with diverse applications in both oncology and non-oncology fields . Despite its undeniable clinical utility, FDG uptake serves as an alternative indicator for glucose transport/metabolism rather than being specific to malignant tumors. Continuous exploration of cellular targets has led to the discovery of fibroblast activation protein (FAP). Cancer-associated fibroblasts are present in many tumors, particularly those with strong fibrotic-promoting responses such as breast cancer, colorectal cancer, pancreatic cancer, prostate cancer, and lung cancer. Consequently, FAP expression has been observed in over 90% of epithelial tumors. To date, FAP expression has been associated with poor tumor prognosis in colorectal cancer, pancreatic cancer, hepatocellular carcinoma, and ovarian cancer . Although more research is needed, this advantage makes cancer-associated fibroblasts an ideal target for anti-tumor therapy. In practical applications, low FAP expression in fibroblasts or healthy tissues facilitates imaging of subtle pathological changes. Cancer-associated fibroblasts (CAFs), a key component of the tumor microenvironment, account for over half the mass in various tumor types. Previous studies indicate that CAFs play significant roles in tumor growth, immune suppression, and cancer invasion . Therefore, CAFs may become emerging targets for tumor diagnosis and treatment. Fibroblast activation protein (FAP) is overexpressed in CAFs of multiple epithelial cancers but shows weak expression in healthy tissues, making it a promising target in cancer research. Recent years have seen expanded molecular imaging studies targeting FAP in tumor diagnosis . The excellent tumor-targeting efficacy of FAP has been confirmed through multiple clinical trials . The results clearly establish FAPI as a highly promising tumor-targeting ligand with significant potential applications in translational oncology. However, its therapeutic efficacy remains under investigation. An ideal radiopharmaceutical for cancer treatment should demonstrate excellent targeting specificity and relatively long tumor retention time. Previous studies have shown that radiolabeled FAPI variants (FAPI-04 and FAPI-46) accumulate rapidly and satisfactorily in tumors while showing low physiological uptake in normal tissues. However, previous FAP-related tracers exhibited relatively short tumor retention times . Our aim is to design a FAPI trimer, Trap-(FAPI)3, to optimize pharmacokinetics and evaluate whether this novel drug demonstrates superior advantages over its monomeric analogs in tumor imaging diagnosis and staging.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy

  The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-Trap-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.

  Completed within half year after end of the study

Study Arms (1)

Patients with malignant tumors

a) Age between 18 and 65 years, gender not limited; b) Patients with malignant tumors confirmed by biopsy or surgical pathology; c) Imaging findings of suspicious lymph nodes or distant metastases; d) Written informed consent from the subject or his/her legal guardian.

Eligibility Criteria

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

Study Population

The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn.

You may qualify if:

• Age between 18 and 65 years old, gender is not limited
• Patients with malignant tumors confirmed by biopsy or surgical pathology
• Suspected lymph node or distant metastasis found by imaging
• Written informed consent signed by the subject or his/her legal guardian

You may not qualify if:

• Patients receiving anti-tumor therapy prior to PET/CT or PET/MR scans
• Patients with severe medical conditions unable to tolerate PET/CT or PET/MR scans
• Eligible participants with contraindications for PET/CT or PET/MR scans
• Participants with radiation exposure exceeding 50 mSv in the past year
• Participants who underwent major surgery within the last three months or received experimental drugs/instruments (with unclear efficacy/safety) within one month
• Participants with clinical conditions that the study sponsor considers potentially hazardous or harmful to this investigational agent.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

• Tan Y, Li J, Zhao T, Zhou M, Liu K, Xiang S, Tang Y, Jakobsson V, Xu P, Chen X, Zhang J. Clinical translation of a novel FAPI dimer [68Ga]Ga-LNC1013. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2761-2773. doi: 10.1007/s00259-024-06703-z. Epub 2024 Apr 2.

  PMID: 38561515 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

histopathological findings obtained from biopsy or resected surgical specimens

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 17, 2025
• Study Start: August 13, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)