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68Ga-FAPI PET/CT in Patients With Various Types of Cancer

Primary Purpose

Tumor, Positron-Emission Tomography, Metastasis

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

68Ga-DOTA/NOTA-FAPI-04

PET/CT scan

About this trial

This is an interventional diagnostic trial for Tumor

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 new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (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

The First Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: 68Ga-DOTA/NOTA-FAPI-04

Arm Description

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

Outcomes

Primary Outcome Measures

Standardized uptake value (SUV)

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

Secondary Outcome Measures

Diagnostic efficacy

The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Diagnostic efficacy

The positive predictive value (PPV), negative predictive value (NPV)

Full Information

NCT ID

NCT04499365

First Posted

August 1, 2020

Last Updated

September 5, 2020

Sponsor

First Affiliated Hospital of Fujian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04499365

Brief Title

68Ga-FAPI PET/CT in Patients With Various Types of Cancer

Official Title

68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2020 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 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 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

6. Conditions and Keywords

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

Tumor, Positron-Emission Tomography, Metastasis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: 68Ga-DOTA/NOTA-FAPI-04

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

68Ga-DOTA/NOTA-FAPI-04

Intervention Description

Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.

Intervention Type

Diagnostic Test

Intervention Name(s)

PET/CT scan

Intervention Description

PET/CT scan

Primary Outcome Measure Information:

Title

Standardized uptake value (SUV)

Description

Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-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

The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Time Frame

30 days

Title

Diagnostic efficacy

Description

The positive predictive value (PPV), negative predictive value (NPV)

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 new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (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

Weibing Miao, MD

Phone

86-0591-87981618

miaoweibing@126.com

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

Shan Zheng, MD

Phone

86-0591-87981619

zhengshan1982@126.com

Facility Information:

Facility Name

The First Affiliated Hospital of Fujian Medical University

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350005

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weibing Miao, MD

Phone

86-0591-87981618

miaoweibing@126.com

First Name & Middle Initial & Last Name & Degree

Shan Zheng, MD

Phone

86-0591-87981619

zhengshan1982@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35551610

Citation

Chen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12.

Results Reference

derived

PubMed Identifier

34424505

Citation

Zheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23.

Results Reference

derived

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68Ga-FAPI PET/CT in Patients With Various Types of Cancer

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