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.
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
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Positron Emission Tomography
- 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.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, 519000
Hongjun Jin, Ph.D, 0756-2526136, jinhj3@mail.sysu.edu.cn
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 group | Role | What they receive |
|---|---|---|
| N0 stage | Other | patients without malignant lymph nodes Receives: Diagnostic Test: Dynamic PET |
| Non-N0 stage | Other | patients 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.
Ki comparison between MLNs and BLNs
Ki of each MLN and BLN were calculated and compared
Measured: 60 minutes
MRglu comparison between MLNs and BLNs
MRglu of each MLN and BLN were calculated and compared
Measured: 60 minutes
SUVmax comparison between MLNs and BLNs
SUVmax of each MLN and BLN were calculated and compared
Measured: 60 minutes
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)
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
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
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
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.
- First posted17 Aug 2020
- Study start1 Mar 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Shan, Ph.D, Study chair, Fifth Affiliated Hospital, Sun Yat-Sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04514822
- Acronym / sponsor ID
- ZDWY.FZYX.006
- Keywords
- Esophageal squamous cell carcinoma, metastatic lymph nodes, positron emission tomography, glucose metabolic rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N0 stage | Other | Diagnostic Test: Dynamic PETpatients without malignant lymph nodes |
| Non-N0 stage | Other | Diagnostic Test: Dynamic PETpatients with malignant lymph nodes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ·Patients who were pathologically confirmed ESCC at Sun Yet-sen Fifth Affiliated Hospital.
Key exclusion criteria (4 listed)
- diabetes mellitus
- fasted glucose level ≥ 11.0 mmol/L
- breast feeding
- pregnancy and clustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic PETAlso: Static PETAfter 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. | Diagnostic test | N0 stage, Non-N0 stage |
Primary outcome
Ki comparison between MLNs and BLNs
Time frame: 60 minutes
Ki of each MLN and BLN were calculated and compared
MRglu comparison between MLNs and BLNs
Time frame: 60 minutes
MRglu of each MLN and BLN were calculated and compared
SUVmax comparison between MLNs and BLNs
Time frame: 60 minutes
SUVmax of each MLN and BLN were calculated and compared
SUVmax 60/30 comparison between MLNs and BLNs
Time frame: 60 minutes
SUVmax 60/30 of each MLN and BLN were calculated and compared
4 secondary outcomes
Ki comparison from PTs between N0 and non-N0 stage
Time frame: 60 minutes
MRglu comparison from PTs between N0 and non-N0 stage
Time frame: 60 minutes
SUVmax comparison from PTs between N0 and non-N0 stage
Time frame: 60 minutes
SUVmax 60/30 comparison from PTs between N0 and non-N0 stage
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Shan, Ph.D study chair
Fifth Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
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.