A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma

Pancreas Adenocarcinoma Clinical Trial

Official title:

A Study Using 18F-FAPI PET to Evaluate Pathologic Response to Systemic Treatment in Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277206
• Other study ID #: FAPIPDAC02
• Status: Completed
• Start date: August 4, 2021
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 10, 2024
• Est. primary completion date: November 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• suspected to have pancreatic cancer by radiological imaging
• planned systemic treatment
• possibility of conversion surgery
• willingness to participate the study

Exclusion Criteria:

• without pathologically confirmed pancreatic cancer
• poor performance status or organ functions that cannot meet the systemic treatment requirements
• metastatic disease
• pregnant patients

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Adenocarcinoma
• Systemic Treatment

Intervention

Diagnostic Test:
• 18F-FAPI PET/CT
Enrolled patients underwent 18F-FAPI PET/CT at diagnosis. And preoperative 18F-FAPI PET/CT was completed in the patients met the criteria for conversion surgery after systemic treatment. The correlation between changes of parameters before and after treatment and pathologic response was analyzed.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Medical College of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Maximum standardized uptake value	Change of SUVmax before and after treatment	Baseline and preoperation
Primary	Change of Mean standardized uptake value	Change of SUVmean before and after treatment	Baseline and preoperation
Secondary	Maximum standardized uptake value	Baseline SUVmax at diagnosis	Baseline
Secondary	Mean standardized uptake value	Baseline SUVmean at diagnosis	Baseline
Secondary	Metabolic Tumor Volume	Baseline MTV at diagnosis	Baseline
Secondary	Total Lesion FAP expression	Baseline TLF at diagnosis	Baseline
Secondary	Change of Metabolic Tumor Volume	Change of MTV before and after treatment	Baseline and preoperation
Secondary	Change of Total Lesion FAP expression	Change of TLF before and after treatment	Baseline and preoperation