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

Primary Purpose

Esophageal Squamous Cell Carcinoma, Positron Emission Tomography

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dynamic PET
Sponsored by
Fifth Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, metastatic lymph nodes, positron emission tomography, glucose metabolic rate

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Fifth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

N0 stage

Non-N0 stage

Arm Description

patients without malignant lymph nodes

patients with malignant lymph nodes

Outcomes

Primary Outcome Measures

Ki comparison between MLNs and BLNs
Ki of each MLN and BLN were calculated and compared
MRglu comparison between MLNs and BLNs
MRglu of each MLN and BLN were calculated and compared
SUVmax comparison between MLNs and BLNs
SUVmax of each MLN and BLN were calculated and compared
SUVmax 60/30 comparison between MLNs and BLNs
SUVmax 60/30 of each MLN and BLN were calculated and compared

Secondary Outcome Measures

Ki comparison from PTs between N0 and non-N0 stage
Ki of each primary tumor between N0 and non-N0 stagewere calculated and compared
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.
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.
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

Full Information

First Posted
May 10, 2020
Last Updated
February 2, 2021
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04514822
Brief Title
Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 18F-FDG PET/CT in Patients With ESCC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Positron Emission Tomography
Keywords
Esophageal squamous cell carcinoma, metastatic lymph nodes, positron emission tomography, glucose metabolic rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N0 stage
Arm Type
Other
Arm Description
patients without malignant lymph nodes
Arm Title
Non-N0 stage
Arm Type
Other
Arm Description
patients with malignant lymph nodes
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic PET
Other Intervention Name(s)
Static PET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ki comparison between MLNs and BLNs
Description
Ki of each MLN and BLN were calculated and compared
Time Frame
60 minutes
Title
MRglu comparison between MLNs and BLNs
Description
MRglu of each MLN and BLN were calculated and compared
Time Frame
60 minutes
Title
SUVmax comparison between MLNs and BLNs
Description
SUVmax of each MLN and BLN were calculated and compared
Time Frame
60 minutes
Title
SUVmax 60/30 comparison between MLNs and BLNs
Description
SUVmax 60/30 of each MLN and BLN were calculated and compared
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Ki comparison from PTs between N0 and non-N0 stage
Description
Ki of each primary tumor between N0 and non-N0 stagewere calculated and compared
Time Frame
60 minutes
Title
MRglu comparison from PTs between N0 and non-N0 stage
Description
MRglu of each primary tumor between N0 and non-N0 stagewere calculated and comparedtumor were calculated.
Time Frame
60 minutes
Title
SUVmax comparison from PTs between N0 and non-N0 stage
Description
SUVmax of each primary tumor between N0 and non-N0 stagewere calculated and comparedtumor were calculated.
Time Frame
60 minutes
Title
SUVmax 60/30 comparison from PTs between N0 and non-N0 stage
Description
SUVmax 60/30 of each primary tumor between N0 and non-N0 stagewere calculated and compared
Time Frame
60 minutes
Other Pre-specified Outcome Measures:
Title
Sensitivity
Description
The sensitivity for each parameter in differentiating malignant and benign lymph nodes were evaluated
Time Frame
60 minutes
Title
Specificity
Description
The specificity for each parameter in differentiating malignant and benign lymph nodes were evaluated
Time Frame
60 minutes
Title
Accuracy
Description
The accuracy for each parameter in differentiating malignant and benign lymph nodes were evaluated
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjun Jin, Ph.D
Phone
0756-2526136
Email
jinhj3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Shan, Ph.D
Organizational Affiliation
Fifth Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The Fifth Affiliated Hospital, Sun Yat-sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjun Jin, Ph.D
Phone
0756-2526136
Email
jinhj3@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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