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Esophageal Squamous Cell CarcinomaNCT04514822

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

A study testing Dynamic PET in people with Esophageal Squamous Cell Carcinoma and Positron Emission Tomography, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Dynamic PET
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Mar 2019to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hongjun Jin, Ph.D contact

0756-2526136

jinhj3@mail.sysu.edu.cn

China1 site, 1 recruiting
  • The Fifth Affiliated Hospital, Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Hongjun Jin, Ph.D, 0756-2526136, jinhj3@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Dynamic PET
Keywords
Esophageal squamous cell carcinoma, metastatic lymph nodes, positron emission tomography, glucose metabolic rate
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic PETDiagnostic test

    Also called Static 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.

Study groups in NCT04514822
Study groupRoleWhat they receive
N0 stageOtherpatients without malignant lymph nodes
Receives: Diagnostic Test: Dynamic PET
Non-N0 stageOtherpatients with malignant lymph nodes
Receives: Diagnostic Test: Dynamic PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ki comparison between MLNs and BLNs

    Ki of each MLN and BLN were calculated and compared

    Measured: 60 minutes

  2. MRglu comparison between MLNs and BLNs

    MRglu of each MLN and BLN were calculated and compared

    Measured: 60 minutes

  3. SUVmax comparison between MLNs and BLNs

    SUVmax of each MLN and BLN were calculated and compared

    Measured: 60 minutes

  4. SUVmax 60/30 comparison between MLNs and BLNs

    SUVmax 60/30 of each MLN and BLN were calculated and compared

    Measured: 60 minutes

Secondary outcomes (4)
  1. Ki comparison from PTs between N0 and non-N0 stage

    Ki of each primary tumor between N0 and non-N0 stagewere calculated and compared

    Measured: 60 minutes

  2. 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.

    Measured: 60 minutes

  3. 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.

    Measured: 60 minutes

  4. 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

    Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start1 Mar 2019
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514822
Sponsor's protocol ID
ZDWY.FZYX.006
Status last verified
Feb 2020
First submitted
10 May 2020
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic PET in people with Esophageal Squamous Cell Carcinoma and Positron Emission Tomography, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongjun Jin, Ph.D (0756-2526136, jinhj3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ki comparison between MLNs and BLNs (time frame: 60 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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