Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts

NCT ID: NCT05442151

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FAPI-PET/CT group

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients who meet any of the following conditions.

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

Exclusion Criteria

1. Pregnant women or patients who may be pregnant
2. Pediatric patients requiring sedation
3. Those who are judged to be inappropriate as subjects.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tadashi Watabe

OTHER

Sponsor Role lead

Responsible Party

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Tadashi Watabe

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Osaka University Hospital

Suita, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Tadashi Watabe, M.D., Ph.D.

Role: CONTACT

+81-6-6879-3461

Facility Contacts

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Tadashi Watabe, M.D., Ph.D.

Role: primary

+81-6-6879-3461

References

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Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.

Reference Type BACKGROUND
PMID: 34420105 (View on PubMed)

Other Identifiers

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21472

Identifier Type: -

Identifier Source: org_study_id

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