Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514822
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2020-05-10
Brief Title:
Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 18F-FDG PETCT in Patients With ESCC
Sponsor:
Fifth Affiliated Hospital Sun Yat-Sen University
Organization:
Fifth Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Quantitative Evaluation of Metastatic Lymph Nodes With Dynamic 2-18FFluoro-2-deoxy-glucose 18F-FDG Positron Emission TomographyComputed Tomography in Patients With Esophageal Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently static scans are commonly used for Positron Emission TomographyComputed Tomography PETCT examination in the literature Accordingly functional images of 2-18Ffluoro-2-deoxy-glucose 18F-FDG Positron Emission TomographyComputed Tomography PETCT 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 PETCT 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 572034 new cases and 508585 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 PETcomputed 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 tracer2-18Ffluoro-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 PETCT 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 inflammatoryinfectious or normal tissues Shum et al ever assessed clinical usefulness of dual-time FDG PETCT 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 25 or retention index RI 10 was 962 However for loco-regional lymph node detection there was no significant difference using dual-time 18F-FDG PETCT assessment Dynamic 18F-FDG PETCT 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 PETCT imaging 0-60 min add additional value in differentiation MLN from BLN
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 PETcomputed 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 tracer2-18Ffluoro-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 PETCT 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 inflammatoryinfectious or normal tissues Shum et al ever assessed clinical usefulness of dual-time FDG PETCT 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 25 or retention index RI 10 was 962 However for loco-regional lymph node detection there was no significant difference using dual-time 18F-FDG PETCT assessment Dynamic 18F-FDG PETCT 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 PETCT imaging 0-60 min add additional value in differentiation MLN from BLN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None