NCT04514822

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2020

Enrollment Period

3.8 years

First QC Date

May 10, 2020

Last Update Submit

February 2, 2021

Conditions

Esophageal Squamous Cell CarcinomaPositron Emission Tomography

Keywords

Esophageal squamous cell carcinomametastatic lymph nodespositron emission tomographyglucose metabolic rate

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Ki comparison from PTs between N0 and non-N0 stage

    60 minutes

  • MRglu comparison from PTs between N0 and non-N0 stage

    60 minutes

  • SUVmax comparison from PTs between N0 and non-N0 stage

    60 minutes

  • SUVmax 60/30 comparison from PTs between N0 and non-N0 stage

    60 minutes

Other Outcomes (3)

  • Sensitivity

    60 minutes

  • Specificity

    60 minutes

  • Accuracy

    60 minutes

Study Arms (2)

N0 stage

OTHER

patients without malignant lymph nodes

Diagnostic Test: Dynamic PET

Non-N0 stage

OTHER

patients with malignant lymph nodes

Diagnostic Test: Dynamic PET

Interventions

Dynamic PETDIAGNOSTIC_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-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.

Also known as: Static PET
N0 stageNon-N0 stage

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Hong Shan, Ph.D

    Fifth Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Hongjun Jin, Ph.D

CONTACT

0756-2526136jinhj3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

August 17, 2020

Study Start

March 1, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

February 4, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)