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First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

NCT ID: NCT05814835

Last Updated: 2023-12-20

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2023-12-18

Brief Summary

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This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Detailed Description

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20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.

Conditions

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Malignant Solid Tumors

Keywords

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68Ga-FAPI 64Cu-FAPI

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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68Ga/64Cu-FAPI-XT117 PET/CT

Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.

Group Type EXPERIMENTAL

2-4 mCi 68Ga/64Cu-FAPI-XT117

Intervention Type DRUG

68Ga/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 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection.

4-6 mCi 68Ga/64Cu-FAPI-XT117

Intervention Type DRUG

68Ga/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 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection.

6-8 mCi 68Ga/64Cu-FAPI-XT117

Intervention Type DRUG

68Ga/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 6-8 mCi 68Ga/64Cu-FAPI-XT117 injection.

Interventions

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2-4 mCi 68Ga/64Cu-FAPI-XT117

68Ga/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 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection.

Intervention Type DRUG

4-6 mCi 68Ga/64Cu-FAPI-XT117

68Ga/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 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection.

Intervention Type DRUG

6-8 mCi 68Ga/64Cu-FAPI-XT117

68Ga/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 6-8 mCi 68Ga/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

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruimin Wang

chief of nuclear medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruimin Wang

Role: PRINCIPAL_INVESTIGATOR

the First Medical Center, Chinese PLA General Hospital

Locations

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the First Medical Center, Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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XT-XTR016-1-01

Identifier Type: -

Identifier Source: org_study_id