Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 18F-FDG PET/CT in Patients With ESCC

Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 2-[18F]Fluoro-2-deoxy-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography in Patients With Esophageal Squamous Cell Carcinoma

Currently, static scans are commonly used for Positron Emission Tomography/Computed Tomography (PET/CT) examination in the literature. Accordingly, functional images of 2-[18F]fluoro-2-deoxy-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) with dynamic scans can be more sensitive to detect metastatic lymph node, since the introduction of temporal dynamic variables would provide more imaging quantification than conventional static scans. The purpose of this study is to provide the dynamic 18F-FDG PET/CT imaging for esophageal squamous cell carcinoma (ESCC) patient to quantify the difference between malignant lymph nodes (MLN) and benign lymph nodes (BLN).

Study Overview

• Status: Recruiting
• Conditions: Esophageal Squamous Cell Carcinoma; Positron Emission Tomography
• Intervention / Treatment: Diagnostic test: Dynamic PET

Detailed Description

Esophageal cancer is one of the most aggressive malignancies in the world, which accounted for an estimated 572,034 new cases and 508,585 deaths in 2018 worldwide. The incidence and mortality of esophageal cancer is ranked first in China and esophageal squamous cell carcinoma (ESCC) is the main histological subtype of esophageal cancers in China. Correct preoperative evaluation of whether the tumor has reached any lymph nodes is important for management. Various methods have been used to detect primary and lymph node metastases in esophageal cancer patients, including computed tomography (CT), endoscopic examinations, and endoscopic ultrasonography (EUS). However, even such advanced imaging modalities do not always reliably identify lymph node metastasis prior to surgical resection and pathological examination.

The appearance of lymph nodes with morphological imaging procedures is classified by their shape, size, density and, if applied, contrast enhancement. BLN usually tend to have a fatty hilum, an oval shape and frequently do not measure more than 1 cm in the short axis diameter. However, the use of size as the most important criterion for differentiation of benign and malignant lymph nodes has limitations: small metastases without an increase in lymph node size are frequently missed. Positron emission tomography (PET)/computed tomography (CT) is increasingly used as single "one stop shop" method, which the combination of morphological and functional imaging represents the optimal approach for lymph node staging and general staging. A radioactive tracer，2-[18F]fluoro-2-deoxy-glucose (18F-FDG) currently used is based on the increased glucose metabolism, which may be reported with semiquantitative standard uptake value (SUV). Routinely, 18F-FDG is intravenous injected and PET/CT scan is performed after 60 min. The static imaging in differentiation of inflammatory from MLN may be problematic. Because inflammatory lymph nodes goes along with an increase in glucose metabolism, and thus may manifest increased 18F-FDG uptake. It was reported that PET-CT sensitivity and specificity for the detection of loco-regional metastases were moderate, but sensitivity and specificity were reasonable for distant metastases. Many researchers found there is a correlation between the 18F-FDG uptake and time. In malignancy, the uptake of FDG uptake continues to increase for several hours after FDG injection whereas such prolonged period of FDG uptake is rare in inflammatory/infectious or normal tissues. Shum et al ever assessed clinical usefulness of dual-time FDG PET/CT in esophageal squamous cell carcinoma, which turned out the sensitivity of FDG PET-CT in detecting the primary ESCC with combination of early maximum standard uptake value (SUVmax) ≥2.5 or retention index (RI) ≥10% was 96.2%. However, for loco-regional lymph node detection, there was no significant difference using dual-time 18F-FDG PET/CT assessment. Dynamic 18F-FDG PET/CT allows quantitative assessment of lesion in vivo by using a Patlak model to obtain the influx constant (Ki), and the glucose metabolic rate (MRglu). The purpose of the study is to determine whether the dynamic 18F-FDG PET/CT imaging (0-60 min) add additional value in differentiation MLN from BLN.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongjun Jin, Ph.D; Phone Number: 0756-2526136; Email: jinhj3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital, Sun Yat-sen University
      • Contact: Hongjun Jin, Ph.D; Phone Number: 0756-2526136; Email: jinhj3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

·Patients who were pathologically confirmed ESCC at Sun Yet-sen Fifth Affiliated Hospital.

Exclusion Criteria:

• diabetes mellitus
• fasted glucose level ≥ 11.0 mmol/L
• breast feeding
• pregnancy and clustrophobia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: N0 stage; patients without malignant lymph nodes	Diagnostic test: Dynamic PET; 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-FDG 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.; Other Names: Static PET
OTHER: Non-N0 stage; patients with malignant lymph nodes	Diagnostic test: Dynamic PET; 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-FDG 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.; Other Names: Static PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ki comparison between MLNs and BLNs	Ki of each MLN and BLN were calculated and compared	60 minutes
MRglu comparison between MLNs and BLNs	MRglu of each MLN and BLN were calculated and compared	60 minutes
SUVmax comparison between MLNs and BLNs	SUVmax of each MLN and BLN were calculated and compared	60 minutes
SUVmax 60/30 comparison between MLNs and BLNs	SUVmax 60/30 of each MLN and BLN were calculated and compared	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ki comparison from PTs between N0 and non-N0 stage	Ki of each primary tumor between N0 and non-N0 stagewere calculated and compared	60 minutes
MRglu comparison from PTs between N0 and non-N0 stage	MRglu of each primary tumor between N0 and non-N0 stagewere calculated and comparedtumor were calculated.	60 minutes
SUVmax comparison from PTs between N0 and non-N0 stage	SUVmax of each primary tumor between N0 and non-N0 stagewere calculated and comparedtumor were calculated.	60 minutes
SUVmax 60/30 comparison from PTs between N0 and non-N0 stage	SUVmax 60/30 of each primary tumor between N0 and non-N0 stagewere calculated and compared	60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity for each parameter in differentiating malignant and benign lymph nodes were evaluated	60 minutes
Specificity	The specificity for each parameter in differentiating malignant and benign lymph nodes were evaluated	60 minutes
Accuracy	The accuracy for each parameter in differentiating malignant and benign lymph nodes were evaluated	60 minutes

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Chair: Hong Shan, Ph.D, Fifth Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (ACTUAL): August 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: positron emission tomography; Esophageal squamous cell carcinoma; metastatic lymph nodes; glucose metabolic rate
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: ZDWY.FZYX.006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No