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Comparison of FDG and FAPI in Patients With Various Types of Cancer

Primary Purpose

Tumor, Solid, Positron-Emission Tomography, Metastasis

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT

About this trial

This is an interventional diagnostic trial for Tumor, Solid focused on measuring Positron-Emission Tomography, Tumor, Solid, Diagnosis, Metastasis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

(i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Sites / Locations

First affiliated hospital of xiamen universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: 68Ga-DOTA-FAPI-04

Arm Description

Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

Outcomes

Primary Outcome Measures

SUV

Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary Outcome Measures

Diagnostic efficacy

The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Full Information

NCT ID

NCT04416165

First Posted

June 1, 2020

Last Updated

August 6, 2023

Sponsor

The First Affiliated Hospital of Xiamen University

1. Study Identification

Unique Protocol Identification Number

NCT04416165

Brief Title

Comparison of FDG and FAPI in Patients With Various Types of Cancer

Official Title

Comparison of FDG and FAPI in Patients With Various Types of Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2019 (Actual)

Primary Completion Date

December 30, 2027 (Anticipated)

Study Completion Date

December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Detailed Description

Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumor, Solid, Positron-Emission Tomography, Metastasis

Keywords

Positron-Emission Tomography, Tumor, Solid, Diagnosis, Metastasis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Subjects with various types of cancer undergo contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.

Masking

None (Open Label)

Allocation

N/A

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: 68Ga-DOTA-FAPI-04

Arm Type

Experimental

Arm Description

Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

Intervention Type

Diagnostic Test

Intervention Name(s)

18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT

Intervention Description

Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

Primary Outcome Measure Information:

Title

SUV

Description

Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Diagnostic efficacy

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hua Wu, PhD

Phone

86 0592-2137166

wuhua1025@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Haojun Chen, PhD

Phone

86 0592-2137166

leochen0821@foxmail.com

Facility Information:

Facility Name

First affiliated hospital of xiamen university

City

XiaMen

State/Province

Fujian

ZIP/Postal Code

0086-361000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hua Wu, doctor

Phone

18659285282

wuhua1025@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33179149

Citation

Guo W, Pang Y, Yao L, Zhao L, Fan C, Ke J, Guo P, Hao B, Fu H, Xie C, Lin Q, Wu H, Sun L, Chen H. Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1604-1617. doi: 10.1007/s00259-020-05095-0. Epub 2020 Nov 11.

Results Reference

derived

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Comparison of FDG and FAPI in Patients With Various Types of Cancer

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