68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma

Not Applicable

• Conditions: PDAC
• Interventions: Diagnostic Test: 68Ga-FAPI Positron Emission Tomography-Computed Tomography

• Registration Number: NCT05275985
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (PDAC). In this prospective study, we aimed to evaluate the performance and value of 68Ga-FAPI-04 PET/CT in the patients with PDAC.

Detailed Description

With an incidence rate of 10 cases per 100,000 people per year, cancer of the pancreas is the third most common malignancy of the gastrointestinal tract. The overall survival for patients with pancreatic cancer is very poor, with a 5-year survival of 1% to 4%. Successful therapy depends on early diagnosis. The discrimination between benign and malignancies of the pancreas and the assessment of local resectability and distant metastases of the pancreatic cancer remains challenging with different imaging modalities such as ultrasound (US), endoscopic US (EUS), multidetector row computed tomography (MDCT), magnetic resonance imaging (MRI), and 18F-FDG positron emission tomography (PET). PDAC is characterized by a distinct and exuberant desmoplastic stroma, with stromal components outnumbering the pancreatic cancer cells. In PDAC, more than 90% of the tumour volume consists of cancer-associated fibroblasts (CAF). Fibroblast activation protein (FAP) is highly and selectively expressed in CAFs but is weakly expressed or not detected in normal tissues. The aim of this study was to evaluate the impact of FAPI-PET/CT on the clinical management of patients with suspected pancreatic cancer.

Study Timeline

• Study First Submitted: 2022-02-20
• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11
• Primary Completion: 2022-11-30
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients with suspected pancreatic lesions
2. Signed written consent.

Exclusion Criteria

1. pregnancy;
2. breastfeeding;
3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI PET/CT examination	68Ga-FAPI Positron Emission Tomography-Computed Tomography	Patients with suspected pancreatic lesions underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The clinicians decided the treatment methods based on the results of 68Ga-FAPI PET/CT.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion, an average of 2 year	Determination the overall survival of included patients
The numbers of lesions	through study completion, an average of 0.5 year	Determination the lesions numbers were detected by 68Ga-FAPI
Standard Uptake Value (SUV）	through study completion, an average of 0.5 year	Determined and compared the SUV for detected lesions in 68Ga-FAPI
The numbers of patients who been changed the treatment methods	through study completion, an average of 0.5 year	Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET
Progression Free Survival (PFS)	through study completion, an average of 1 year	Determination the progression free survival of included patients

Trial Locations

Locations (1)

Peking Union Medical College Hospita; 🇨🇳 Beijing, Beijing, China