NCT05884463

Brief Summary

To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

May 22, 2023

Last Update Submit

May 31, 2023

Conditions

18F-FAPI18F-FDGPancreas AdenocarcinomaDiagnosisStaging

Outcome Measures

Primary Outcomes (2)

  • Diagnostic value

    Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT

    1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

  • Maximum standardized uptake value

    SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT

    1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

Secondary Outcomes (5)

  • Diagnostic efficacy for primary lesions

    1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

  • SUVmax for primary lesions

    1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

  • SUVmax for lymph node

    1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

  • SUVmax for distant metastasis

    1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

  • Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response

    at least 2 months after treatment

Study Arms (1)

Experimental

EXPERIMENTAL

Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan

Drug: 18F-FAPIDrug: 18F-FDG

Interventions

18F-FAPIDRUG

Intravenous injection of one dosage of 18F-FAPI.

Also known as: (18)F-FAPI
Experimental
18F-FDGDRUG

Intravenous injection of one dosage of 18F-FDG.

Also known as: (18)F-FDG
Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.

You may not qualify if:

  • patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

  • Li X, Lu N, Lin L, Chen Y, Yang S, Wang H, Liu X, Wu C, Xue X, Su X, Bai X, Liang T. 18F-FAPI-04 Outperforms 18F-FDG PET/CT in Clinical Assessments of Patients with Pancreatic Adenocarcinoma. J Nucl Med. 2024 Feb 1;65(2):206-212. doi: 10.2967/jnumed.123.266283.

    PMID: 38176719DERIVED

MeSH Terms

Conditions

Disease

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Tingbo Liang, Ph.D., M.D.

    Zhejiang University

    STUDY DIRECTOR

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
Professor

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

April 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

CN(1)