68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma

PDAC Clinical Trial

Official title:

A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275985
• Other study ID #: PekingUMCH-FAPIPDAC
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: Jie Ding, MD.
• Phone: +86 17810259215
• Email: 707462902[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ductal
• Carcinoma, Pancreatic Ductal
• PDAC

Intervention

Diagnostic Test:
• 68Ga-FAPI Positron Emission Tomography-Computed Tomography
The patients with suspected pancreatic lesions were included. They underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The treatment methods were decided according to the results of 68Ga-FAPI PET/CT.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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