Quantitative Analysis of 18F-FAPI Dynamic PET/CT for Accurate Differential Diagnosis of MLN of ESCC

NCT ID: NCT05287880

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2023-12-31

Brief Summary

Patients diagnosed with esophageal squamous cell carcinoma based on clinicopathology, laboratory examination and imaging criteria were selected as the research subjects, and compared with conventional 18F-FDG PET/CT. To evaluate the research value of quantitative analysis of 18F-FAPI PET/CT dynamic imaging in the classification of benign and malignant features of primary esophageal squamous cell carcinoma (ESCC) and lymphatic nodules, lesion localization, outcome and prognosis.

Detailed Description

Esophageal cancer (EC) is the eighth most common cancer in the world. Like most other cancers, the occurrence and progression of ESCC is a multi-stage process that closely affects the treatment approach such as endoscopic therapy, surgery, radiotherapy or chemotherapy, and the location of the lesion also affects whether the patient is suitable for surgical resection.Accurate preoperative assessment of lymph node metastasis, disease progression and lesion location is of great significance for early diagnosis and determination of neoadjuvant therapy.

FAP is highly expressed in activated mesenchymal fibroblasts and pericytes in 90% of common human epithelial tumors, as well as in lesions characterized by activation of mesenchymal tissues.The expression of FAP promotes the development of tumors, so inhibiting FAP can slow down the growth of tumors.Currently, several small molecule FAP inhibitors have been functionalized for imaging studies.Studies have shown high uptake of FAPI in sarcoma, esophageal cancer, breast cancer, bile duct cancer, and lung cancer.

Dynamic PET/CT imaging technology with high sensitivity and specificity introduces time parameters while using the fusion technology of PET and CT, providing accurate anatomical positioning in the four-dimensional space and reflecting detailed functional information at molecular level such as functional and metabolic levels.Accurate diagnosis of metastatic lymph nodes of esophageal squamous cell carcinoma can be realized by exploring the kinetic process of various positron probes from entering the body to non-specific distribution and specific distribution.

Conditions

Esophageal Squamous Cell Carcinoma; Benign Lymph Node Neoplasm; Malignant Lymph Node Neoplasm

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-N0 stage

Patients with malignant lymph nodes.

Dynamic PET/CT

Intervention Type: DIAGNOSTIC_TEST

After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan.

N0 stage

Patients without malignant lymph nodes.

Dynamic PET/CT

Intervention Type: DIAGNOSTIC_TEST

After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan.

Interventions

Dynamic PET/CT

After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan.

Intervention Type: DIAGNOSTIC_TEST

Dynamic PET/CT

After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Esophageal squamous cell carcinoma was diagnosed according to gastroscopy and pathological diagnostic criteria;

2. Age above 18 years old, less than 85 years old, no gender restriction;

3. Untreated patients who have not received surgery, chemotherapy, biotherapy or radiotherapy;

4. Laboratory examination:

(1) General physical condition score ECOG: 0-2; (2) No dysfunction of main organs; (3) Oxygen partial pressure ≥ 10.64kPa; (4) WBC ≥ 4×109 L-1; (5) Routine blood hemoglobin ≥ 9.5 g· DL-1; (6) The absolute count of neutrophils ≥ 1.5×109 L-1; (7) Platelet count ≥ 100×109 L-1; (8) Total bilirubin ≤ 1.5 times the upper limit of normal value; (9) Creatinine ≤ 1.25 times the upper limit of normal value; (10) Creatinine clearance rate ≥ 60 mL ·min-1;

5. Can obtain complete follow-up information, understand the situation of this study and sign the informed consent.

Exclusion Criteria

1. Has had any other malignant tumor within 5 years;

2. Nursing and/or pregnant women;

3. Patients with severe bleeding tendency;

4. Recent severe hemoptysis, severe cough, dyspnea or patients cannot cooperate;

5. Severe emphysema, pulmonary congestion and cor pulmonale;

6. In the opinion of the Investigator, the subject may not be able to complete the study or comply with the requirements of the study (for administrative or other reasons).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hongjun Jin

Role: CONTACT

jinhj3@mail.sysu.edu.cn

0756-2526572

Other Identifiers

ZDWY.FZYX.009

Identifier Type: -

Identifier Source: org_study_id