NCT04554719

Brief Summary

Positron emission tomography (PET) molecular imaging provides a valuable tool for the diagnosis and differential diagnosis, staging of various tumors. Malignant tumor is composed of tumor cells and tumor stroma, which occupies the vast majority of the tumor. Cancer-associated fibroblasts (CAF) are an important part of the tumor stroma. Fibroblast activation protein (FAP) is over-expressed in CAF, which is closely related to tumor growth, invasion, metastasis, immunosuppression and prognosis; and the expression level of FAP in normal tissues and organs is very low. So it becomes an excellent target for cancer diagnosis and treatment. Radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that specifically target to FAP as a tracer for PET imaging can be applied for targeted diagnosis and treatment of cancer. Recently, some studies have found that gallium-68 (68Ga) -FAPI as a new novel positron tracer has shown to be with good application potential. In this prospective study, the investigators will use integrated PET/MR, and PET/CT with the agent 68Ga-FAPI and conventional imaging agent \[F-18\] fluorodeoxyglucose (18F-FDG) to diagnose and stage various cancers, the aim is to make up for the deficiency in FDG PET imaging in the diagnosis and staging of some cancers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

September 2, 2020

Last Update Submit

February 13, 2023

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in some malignant tumors.

    For subjects with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging, diagnosis and staging results of 68Ga-DOTA-FAPI PET/MR, PET/CT will be compared to 18F-FDG PET/CT imaging, pathology, clinical and follow-up result.

    2 years

Study Arms (1)

68Ga-DOTA-FAPI PET/MR

EXPERIMENTAL

Investigators select subjects from patients with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging, focusing on malignant tumors with poor results of FDG PET/CT imaging, such as brain tumors, liver tumors, digestive system tumors and peritoneal, greater omentum, and mesenteric metastatic tumors. Patients undergo 68Ga-DOTA-FAPI PET/MR imaging within one week.

Drug: 68Ga-DOTA-FAPIDevice: PET/MRDevice: PET/CT

Interventions

68Ga-DOTA-FAPIDRUG

Intravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-FAPI dose is about 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.

Also known as: gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)
68Ga-DOTA-FAPI PET/MR
PET/MRDEVICE

Each subject undergoes PET/MR imaging within 40-60 minutes after injection.

Also known as: Positron Emission Tomography/Magnetic Resonance
68Ga-DOTA-FAPI PET/MR
PET/CTDEVICE

Each subject undergoes PET/CT imaging within 40-60 minutes after injection.

Also known as: Positron Emission Tomography/Computed Tomography
68Ga-DOTA-FAPI PET/MR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging.
  • Subjects are able to understand and sign the informed consent voluntarily, with good compliance.

You may not qualify if:

  • Acute systemic diseases and electrolyte disorders.
  • Pregnant or lactating women.
  • Patients refuse to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (4)

  • Qin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3.

    PMID: 35657428DERIVED

  • Qin C, Song Y, Liu X, Gai Y, Liu Q, Ruan W, Liu F, Hu F, Lan X. Increased uptake of 68Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):709-720. doi: 10.1007/s00259-021-05472-3. Epub 2021 Jul 9.

    PMID: 34241652DERIVED

  • Qin C, Liu F, Huang J, Ruan W, Liu Q, Gai Y, Hu F, Jiang D, Hu Y, Yang K, Lan X. A head-to-head comparison of 68Ga-DOTA-FAPI-04 and 18F-FDG PET/MR in patients with nasopharyngeal carcinoma: a prospective study. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3228-3237. doi: 10.1007/s00259-021-05255-w. Epub 2021 Feb 20.

    PMID: 33609152DERIVED

  • Zhang X, Song W, Qin C, Liu F, Lan X. Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2635-2641. doi: 10.1007/s00259-021-05194-6. Epub 2021 Jan 15.

    PMID: 33452634DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Gallium-68Positron-Emission TomographyMagnetic Resonance SpectroscopyPositron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementRadiographyTomography, X-Ray

Study Officials

  • Xiaoli Lan, PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633lxl730724@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of nuclear medicine

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 18, 2020

Study Start

May 22, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 14, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)