68Ga-FAPI PET/CT in Malignant Tumors

NCT05034146 | Recruiting

• 1 other identifier: ZNYYHYXK0001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Conditions

Fibroblast Activation Protein Inhibitor; PET/CT; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors

  Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.

  three years

Secondary Outcomes (3)

• Prognostic value of FAPI PET parameters in malignant tumors

  From baseline to 1 year post-treatment

• FAPI PET for therapeutic response evaluation in malignant tumors

  Within 1 week after completion of neoadjuvant or adjuvant therapy

• The connection between FAPI PET parameters and histopathological biomarkers.

  Within 4 weeks of FAPI PET scan

Study Arms (1)

68Ga-FAPI PET/CT in malignant tumors

EXPERIMENTAL

Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.

Drug: 68Ga-FAPI; Device: PET/CT

Interventions

68Ga-FAPI DRUG

68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).

Also known as: 68Ga-fibroblast activation protein inhibitor

68Ga-FAPI PET/CT in malignant tumors

PET/CT DEVICE

68Ga-FAPI PET/CT scan were performed 20\~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.

Also known as: positron emission tomography/computed tomography

68Ga-FAPI PET/CT in malignant tumors

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor

You may not qualify if:

• Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (6)

• Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.

  PMID: 30954939 BACKGROUND

• Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1.

  PMID: 33258746 BACKGROUND

• Li H, Li C, Tian Y, Xiao Z, Xing D, He Y. Same-day dual-tracer PET/CT imaging with [68 Ga]Ga-FAPI-04 following [18F]FDG finds answers in patients presenting with negative or equivocal [18F]FDG. Ann Nucl Med. 2025 Nov;39(11):1237-1248. doi: 10.1007/s12149-025-02080-1. Epub 2025 Jul 4.

  PMID: 40614035 DERIVED

• Jiang Y, Yu Z, Sun Y, Tian Y, Wang L, Xing D, Huang Y, He Y, Jia J. Predictive value of [68Ga]Ga-FAPI-04 PET/CT on pathologic response to neoadjuvant chemoimmunotherapy for locally advanced resectable oral squamous cell carcinoma. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):283-294. doi: 10.1007/s00259-025-07414-9. Epub 2025 Jun 23.

  PMID: 40548990 DERIVED

• Jiang Y, Huang S, Tian Y, Xing D, Xiao Z, Huang J, He Y. Dual-Time Point 68 Ga-FAPI-04 PET/CT Improves Tumor Delineation and Cervical Lymph Node Metastasis Identification in Patients With Head and Neck Squamous Cell Carcinoma. Clin Nucl Med. 2025 Mar 1;50(3):e130-e137. doi: 10.1097/RLU.0000000000005610. Epub 2024 Dec 13.

  PMID: 39668486 DERIVED

• Chen J, Xu K, Li C, Tian Y, Li L, Wen B, He C, Cai H, He Y. [68Ga]Ga-FAPI-04 PET/CT in the evaluation of epithelial ovarian cancer: comparison with [18F]F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4064-4076. doi: 10.1007/s00259-023-06369-z. Epub 2023 Aug 1.

  PMID: 37526694 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

68Ga-FAPI; Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yong He, MD, PhD

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong He, MD, PhD

CONTACT

+86-27-67812698; vincentheyong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Experimental: 68Ga-FAPI PET/CT Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: February 23, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)