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NCT Number: NCT05442151

Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

PET / CT examination using [18F] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.

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Key information

Conditions

Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location status: Recruiting

About this study

Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and [68Ga] FAPI-04 and [18F] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using [18F] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who meet any of the following conditions.

  • Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
  • Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
  • Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor

Exclusion criteria

  • Pregnant women or patients who may be pregnant
  • Pediatric patients requiring sedation
  • Those who are judged to be inappropriate as subjects.

Treatment and study plan

PET/CT ([F-18]FAPI-74)

Drug

PET/CT using [18F] FAPI-74 injection

Primary outcomes

  1. Comparison of the uptake on FAPI-PET with conventional imaging

    Time frame: Within 2 hours after administration of [F-18]FAPI-74 injection

    Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET

  2. Comparison with pathological specimens

    Time frame: Within one month after FAPI-PET

    Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).)

  3. Time course of uptake on FAPI-PET

    Time frame: Approximately 6 months after initial FAPI-PET

    Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Tadashi Watabe

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2022
Registry last updated
Jul 31, 2025

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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