Fibroblast Activation Protein Inhibitor PET/CT Imaging in Malignant Tumor of Digestive System

Gastrointestinal Cancer Clinical Trial

Official title:

The Application of Molecular Probe Targeting Fibroblast Activation Protein in Malignant Tumor of Digestive System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420558
• Other study ID #: ZNYYPTXM2022013
• Status: Recruiting
• Start date: June 23, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Zhongnan Hospital
• Contact: Chongjiao Li, MD, PhD
• Phone: +86-18827093900
• Email: LCJ0301[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this single center prospective study is to assess the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.

Description:

Malignant tumor of digestive system is one of the most common cancer types worldwide with high cancer-related mortalities. FDG PET/CT is an essential imaging modality in the tumor treatment and management. However, FDG PET/CT has certain limitations. For example, the detection sensitivity and tracer uptake in signet ring cell carcinoma (SRCC) is low. Furthermore, the physiological uptake of the gastrointestinal tract and acute gastroenteritis may mask the detection of lesion in the abdomen and pelvis. Therefore, a novel molecular imaging tracer is needed for the accurate evaluation of malignant tumor of digestive system.

Cancer-associated fibroblasts (CAFs) specifically express fibroblast activation protein (FAP), which is highly expressed by CAFs in more than 90% of human epithelial cancers. FAP-specific small molecule inhibitors (FAPIs) show much advantages over FDG, including high tumor accumulation, low background tissue uptake, and rapid clearance in vivo.

The purpose of this single center prospective study is to assess the value of FAPI PET/CT imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.

In this study, qualitative and quantitative analyses will be used. The diagnostic criteria of FAPI PET/CT: if the FAPI uptake of lesion is higher than that of the surrounding background tissue, it is determined as a positive lesion; if the FAPI uptake of the lesion is the same as or lower than that of the surrounding background tissue, it is determined as a negative lesion. Pathological result is used as the gold standard for diagnosis. The diagnostic performance of FAPI PET/CT including sensitivity, specificity, positive predictive value, negative predictive value, and accuracy will be calculated.

The quantitative indicators include the following metabolic parameters: maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), tumor metabolic volume (MTV), total tumor glycolysis (TLG), tumor-to-liver ratio, and tumor-to-background tissue ratio.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Voluntarily participate and sign the informed consent.

2. Patients with suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.

3. Complete clinical information, biochemical examination results, CT and/or MRI imaging examination, pathological information, and clinical/imaging follow-up data.

Exclusion Criteria:

1. Female patient who plan to become pregnant within 6 months, or pregnant or breast-feeding women.

2. Allergic constitution.

3. Those who are in poor general condition and cannot tolerate PET/CT examination.

4. The researchers believe that he or she is not suitable to participate in this study.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Diagnostic Test:
• Fibroblast activation protein inhibitor PET/CT imaging
All participants will receive a 68Ga-labelled fibroblast activation protein inhibitor PET/CT imaging

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Fu L, Huang S, Wu H, Dong Y, Xie F, Wu R, Zhou K, Tang G, Zhou W. Superiority of [68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT to [18F]FDG PET/CT in delineating the primary tumor and peritoneal metastasis in initial gastric cancer. Eur Radiol. 2022 Sep;32(9):6281-6290. doi: 10.1007/s00330-022-08743-1. Epub 2022 Apr 5. — View Citation

Lin R, Lin Z, Chen Z, Zheng S, Zhang J, Zang J, Miao W. [68Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of gastric cancer: comparison with [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2960-2971. doi: 10.1007/s00259-022-05799-5. Epub 2022 Apr 25. — View Citation

Qin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early postoperative recurrence	Evaluation of the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system	two years
Secondary	diagnostic performance	Evaluation of the diagnostic performance of FAPI PET imaging in detecting malignant tumor of digestive system	18 months