Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

NCT ID: NCT05930457

Last Updated: 2023-12-26

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2023-12-18

Brief Summary

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This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Detailed Description

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Conditions

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Malignant Solid Tumors

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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64Cu-FAPI-XT117 PET/CT

Group Type EXPERIMENTAL

2.5-3.5mCi 64Cu-FAPI-XT117

Intervention Type DRUG

64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2.5-3.5mCi 64Cu-FAPI-XT117 injection.

3.5-4.5mCi 64Cu-FAPI-XT117

Intervention Type DRUG

64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 3.5-4.5mCi 64Cu-FAPI-XT117 injection.

4.5-5.5mCi 64Cu-FAPI-XT117

Intervention Type DRUG

64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4.5-5.5mCi 64Cu-FAPI-XT117 injection.

Interventions

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2.5-3.5mCi 64Cu-FAPI-XT117

64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2.5-3.5mCi 64Cu-FAPI-XT117 injection.

Intervention Type DRUG

3.5-4.5mCi 64Cu-FAPI-XT117

64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 3.5-4.5mCi 64Cu-FAPI-XT117 injection.

Intervention Type DRUG

4.5-5.5mCi 64Cu-FAPI-XT117

64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4.5-5.5mCi 64Cu-FAPI-XT117 injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. signed the informed consent
* 2\. ≥18 years old
* 3\. confirmed as malignant solid tumor by histopathology or clinical judgment
* 4\. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria

* 1\. Known allergy to components of the investigational drug or its analogues
* 2\. suspected to have a certain disease or condition that is not suitable for the study drug
* 3\. Known pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xinlu Wang

chief of nuclear medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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XT-XTR016-1-02

Identifier Type: -

Identifier Source: org_study_id