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Completed

NCT Number: NCT06277206

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

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

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Key information

Conditions

18F-FAPI Pancreas Adenocarcinoma Pathologic Response Systemic Treatment

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FAPI PET/CT

Diagnostic 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.

Primary outcomes

  1. Change of Maximum standardized uptake value

    Time frame: Baseline and preoperation

    Change of SUVmax before and after treatment

  2. Change of Mean standardized uptake value

    Time frame: Baseline and preoperation

    Change of SUVmean before and after treatment

Secondary outcomes

  1. Maximum standardized uptake value

    Time frame: Baseline

    Baseline SUVmax at diagnosis

  2. Mean standardized uptake value

    Time frame: Baseline

    Baseline SUVmean at diagnosis

  3. Metabolic Tumor Volume

    Time frame: Baseline

    Baseline MTV at diagnosis

  4. Total Lesion FAP expression

    Time frame: Baseline

    Baseline TLF at diagnosis

  5. Change of Metabolic Tumor Volume

    Time frame: Baseline and preoperation

    Change of MTV before and after treatment

  6. Change of Total Lesion FAP expression

    Time frame: Baseline and preoperation

    Change of TLF before and after treatment

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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