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Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging in Malignant Tumors

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ClinicalTrials.gov Identifier: NCT04554719
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaoli Lan, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Drug: 68Ga-DOTA-FAPI Device: PET/MR Device: PET/CT Not Applicable

Detailed Description:

Positron emission tomography (PET) molecular imaging provides a valuable tool for the diagnosis and differential diagnosis, staging of various tumors. The most commonly used imaging agent is [F-18] fluorodeoxyglucose (18F-FDG), known as the "molecule of the century". However, in some low-grade gliomas, mucinous adenocarcinoma, bronchoalveolar carcinoma, primary hepatocellular carcinoma, renal clear cell carcinoma and some prostate cancers, factors such as the low expression level of tumor glucose transporter but high level of dephosphorylation, and the low number of tumor cells in tumor tissues can also be manifested as low absorption of 18F-FDG; in addition, 18F-FDG PET has limited ability to detect small lesions in some organs such as brain, liver, and kidneys that have physiological uptake or excretion of FDG with the relatively high background signal; moreover, the distribution of FDG in the body is easily affected by blood sugar. These factors limit the application value of 18F-FDG PET/CT in the differential diagnosis and staging of some malignant tumors.

A 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. The use of radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that specifically bind 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. The probe has very low background uptake in different types of cancer, so it can obtain high image contrast and clear tumor boundary. And it has good stability in serum and can be quickly removed from normal organs in vivo. In this project, we plan to apply the integrated PET / MR imaging of fibroblast activating protein (FAP) in the diagnosis and staging of malignant tumors, and compare it with 18F-FDG PET / CT imaging, so as to make up for the deficiency in FDG PET imaging in the diagnosis and staging of some tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 21, 2022

Arm Intervention/treatment
Experimental: 68Ga-DOTA-FAPI PET/MR
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-FAPI
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.
Other Name: gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)

Device: PET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
Other Name: Positron Emission Tomography/Magnetic Resonance

Device: PET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Other Name: Positron Emission Tomography/Computed Tomography




Primary Outcome Measures :
  1. Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in some malignant tumors. [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554719


Contacts
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Contact: Xiaoli Lan, PhD 0086-027-83692633 lxl730724@hotmail.com

Locations
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China, Hubei
China, Hubei Province Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaoli Lan    0086-027-83692633    lxl730724@hotmail.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Study Director: Xiaoli Lan, PhD Wuhan Union Hospital, China
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Responsible Party: Xiaoli Lan, Director of the Department of nuclear medicine, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04554719    
Other Study ID Numbers: XLan-0290
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms