NCT06277206

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

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

August 4, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

February 17, 2024

Last Update Submit

February 23, 2024

Conditions

18F-FAPIPancreas AdenocarcinomaSystemic TreatmentPathologic Response

Outcome Measures

Primary Outcomes (2)

  • Change of Maximum standardized uptake value

    Change of SUVmax before and after treatment

    Baseline and preoperation

  • Change of Mean standardized uptake value

    Change of SUVmean before and after treatment

    Baseline and preoperation

Secondary Outcomes (6)

  • Maximum standardized uptake value

    Baseline

  • Mean standardized uptake value

    Baseline

  • Metabolic Tumor Volume

    Baseline

  • Total Lesion FAP expression

    Baseline

  • Change of Metabolic Tumor Volume

    Baseline and preoperation

  • +1 more secondary outcomes

Interventions

18F-FAPI PET/CTDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic cancer patients with resectable, borderline or locally advanced disease who plan to undergo systemic treatment, including chemotherpy or chemoimmunotherapy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 26, 2024

Study Start

August 4, 2021

Primary Completion

November 19, 2023

Study Completion

February 10, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)