Back to resultsCombining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients (NPC-LN)
Primary Purpose
Nasopharyngeal Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MRI Scanning
Contrast-Enhanced Ultrasonography
Ultrasound-guided Lymph Node Aspiration
Sponsored by
About this trial
This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Lymph Node, Diagnosis, Contrast-Enhanced Ultrasonography, Magnetic Resonance Imaging, Sonazoid
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group performance status ≤1;
- Patients with histologically confirmed nasopharyngeal carcinoma;
- Tumor staged as T1-4, N0-1/N3, M0 (AJCC 8th);
- On at least one side of the patient's neck, no metastatic lymph nodes were found on MRI according to the current diagnostic criteria, but there were small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level II);
- Patients must be informed of the investigational nature of this study and give written informed consent. And they should be willing and able to comply with the requirements of examination, treatment, follow-up and other research requirements stipulated in the research schedule.
Exclusion Criteria:
- History of other malignant tumors, except for adequately treated basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ;
- Previous radiotherapy, except radiotherapy for non-melanoma skin cancer outside the neck or nasopharyngeal regions;
- Patients with coexistent head and neck squamous cell carcinoma besides nasopharyngeal carcinoma;
- Patients with coexistent acute inflammation or infection (including infection within the area for aspiration);
- Previous surgery or trauma within the neck or nasopharyngeal regions;
- Not suitable for aspiration due to abnormal coagulation function;
- All the candidate small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level II) were not suitable for aspiration owing to high risk of severe complications after the aspiration；
- Contraindications for the examination specified in the research schedule due to claustrophobia, the presence of metal implants or pacemaker, and allergic hypersensitivity to ultrasound contrast agents or MRI contrast agents;
- Other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.
Sites / Locations
- Sun Yat-Sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI Scanning and CEUS for detection of small cervical lymph node metastases.
Arm Description
All patients enrolled will undergo an MRI Scanning and CEUS to evaluate their cervical lymph nodes. Ultrasound-guided lymph node aspiration and pathologic examination will be performed subsequently to obtain definitive diagnosis of the lymph nodes. The pathologic results of the lymph nodes will be adopted as gold standard to evaluate the diagnostic performance of MRI Scanning, CEUS, and the combined diagnostic criteria.
Outcomes
Primary Outcome Measures
Combined Diagnostic Criteria to Diagnose Small Cervical Lymph Node Metastases
The criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid).
Sensitivity and Specificity of the Combined Diagnostic Criteria
Secondary Outcome Measures
Receiver Operating Characteristic Curve and Optimal Cut-off Value of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination
The receiver operating characteristic curve of each characteristics of small lymph nodes in MRI scanning and CEUS examination will be plotted. The area under the curve will be calculated. And the optimal cut-off value of each characteristics will be determined based on the receiver operating characteristic curve.
Diagnostic Performance of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination Based on the Optimal Cut-off Value
The diagnostic performance of each characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with sensitivity, specificity, Youden index, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.
Inter-operator Agreement of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination
The inter-operator agreement of qualitative characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with Cohen's kappa coefficient. The inter-operator agreement of quantitative characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with Bland-Altman analysis and paired t-test.
Diagnostic Performance of the Combined Diagnostic Criteria
The diagnostic performance of the combined diagnostic criteria will be evaluated with area under the receiver operating characteristic curve, Youden index, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.
Inter-operator Agreement of the Combined Diagnostic Criteria
The inter-operator agreement of the combined diagnostic criteria will be evaluated with Cohen's kappa coefficient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389306
Brief Title
Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients
Acronym
NPC-LN
Official Title
Combining MRI Scanning and Contrast-Enhanced Ultrasonography to Diagnose Small Cervical Lymph Node Metastases in Patients With Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
Yes
5. Study Description
Brief Summary
This is a single-center diagnostic accuracy study, with the purpose to define the criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography and evaluate the diagnostic performance of the criteria.
Detailed Description
For newly diagnosed and histologically confirmed nasopharyngeal carcinoma patients staged as T1-4, N0-1/N3, M0 (AJCC 8th), if no metastatic lymph nodes were found on MRI according to the current diagnostic criteria, but there were small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level IIA) on at least one side of the patient's neck, they will be eligible for this study. The MRI image of the small lymph nodes will be evaluated in details by experienced radiologists. Contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid) and ultrasound-guided lymph node aspiration will be performed. Subsequently, the lymph node tissue obtained from ultrasound-guided lymph node aspiration will be subjected to pathologic evaluation. Using the pathologic diagnosis of the lymph node as the gold standard, diagnostic performance of MRI and contrast-enhanced ultrasonography will be evaluated. Resonable criteria to diagnose small cervical lymph node metastases by combining MRI scanning and contrast-enhanced ultrasonography will be explored. And the diagnostic performance of the criteria will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, Lymph Node, Diagnosis, Contrast-Enhanced Ultrasonography, Magnetic Resonance Imaging, Sonazoid
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI Scanning and CEUS for detection of small cervical lymph node metastases.
Arm Type
Experimental
Arm Description
All patients enrolled will undergo an MRI Scanning and CEUS to evaluate their cervical lymph nodes. Ultrasound-guided lymph node aspiration and pathologic examination will be performed subsequently to obtain definitive diagnosis of the lymph nodes. The pathologic results of the lymph nodes will be adopted as gold standard to evaluate the diagnostic performance of MRI Scanning, CEUS, and the combined diagnostic criteria.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI Scanning
Intervention Description
MRI scanning will be performed with a 3.0-T magnetic resonance imaging system with a head and neck-combined coil employing spin-echo technique. The range of the MRI scanning will be from the suprasellar cistern to the inferior margin of the sternal end of the clavicle. The section thicknesses for the axial plane, the sagittal plane and the coronal plane will be 5 mm, 3 mm and 2 mm, respectively. The intersection gaps will be 1 mm. Before the intravenous injection of the MRI contrast agents, T1 weighted images, T2 weighted images and diffusion weighted images will be obtained in the axial planes, while only T1 weighted images will be obtained in the sagittal and coronal planes. After the intravenous injection of the MRI contrast agents, T1-weighted axial sequence, T1-weighted sagittal sequences and T1-weighted fat-suppressed coronal sequence will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast-Enhanced Ultrasonography
Intervention Description
A sonographer equipped with a 6-15 MHz linear array probe will be adopted for contrast-enhanced ultrasonography examination. Conventional high-frequency ultrasonography will be performed firstly before the intravenous injection of the ultrasound contrast agents. Then the ultrasound contrast agents will be injected intravenously, and contrast-enhanced ultrasonography examination will be performed. The mechanical index of contrast-enhanced ultrasonography examination will be 0.23. The wash-in and wash-out process within the lymph node will be dynamically observed during the arterial phase. During the Kupffer-phase, the degree of enhancement will also be observed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound-guided Lymph Node Aspiration
Intervention Description
After the conventional high-frequency ultrasonography and contrast-enhanced ultrasonography examination was finished, ultrasound-guided aspiration of the target lymph node will be performed. The lymph node tissue obtained from ultrasound-guided lymph node aspiration will be subjected to pathologic evaluation. And the diagnostic performance of MRI and contrast-enhanced ultrasonography will be evaluated using the pathologic diagnosis of the lymph node as the gold standard.
Primary Outcome Measure Information:
Title
Combined Diagnostic Criteria to Diagnose Small Cervical Lymph Node Metastases
Description
The criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid).
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
Title
Sensitivity and Specificity of the Combined Diagnostic Criteria
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
Secondary Outcome Measure Information:
Title
Receiver Operating Characteristic Curve and Optimal Cut-off Value of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination
Description
The receiver operating characteristic curve of each characteristics of small lymph nodes in MRI scanning and CEUS examination will be plotted. The area under the curve will be calculated. And the optimal cut-off value of each characteristics will be determined based on the receiver operating characteristic curve.
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
Title
Diagnostic Performance of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination Based on the Optimal Cut-off Value
Description
The diagnostic performance of each characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with sensitivity, specificity, Youden index, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
Title
Inter-operator Agreement of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination
Description
The inter-operator agreement of qualitative characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with Cohen's kappa coefficient. The inter-operator agreement of quantitative characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with Bland-Altman analysis and paired t-test.
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
Title
Diagnostic Performance of the Combined Diagnostic Criteria
Description
The diagnostic performance of the combined diagnostic criteria will be evaluated with area under the receiver operating characteristic curve, Youden index, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
Title
Inter-operator Agreement of the Combined Diagnostic Criteria
Description
The inter-operator agreement of the combined diagnostic criteria will be evaluated with Cohen's kappa coefficient.
Time Frame
The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group performance status ≤1;
Patients with histologically confirmed nasopharyngeal carcinoma;
Tumor staged as T1-4, N0-1/N3, M0 (AJCC 8th);
On at least one side of the patient's neck, no metastatic lymph nodes were found on MRI according to the current diagnostic criteria, but there were small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level IIA);
Patients must be informed of the investigational nature of this study and give written informed consent. And they should be willing and able to comply with the requirements of examination, treatment, follow-up and other research requirements stipulated in the research schedule.
Exclusion Criteria:
History of other malignant tumors, except for adequately treated basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ;
Previous radiotherapy, except radiotherapy for non-melanoma skin cancer outside the neck or nasopharyngeal regions;
Patients with coexistent head and neck squamous cell carcinoma besides nasopharyngeal carcinoma;
Patients with coexistent acute inflammation or infection (including infection within the area for aspiration);
Previous surgery or trauma within the neck or nasopharyngeal regions;
Not suitable for aspiration due to abnormal coagulation function;
All the candidate small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level IIA) were not suitable for aspiration owing to high risk of severe complications after the aspiration；
Contraindications for the examination specified in the research schedule due to claustrophobia, the presence of metal implants or pacemaker, and allergic hypersensitivity to ultrasound contrast agents or MRI contrast agents;
Other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ma, M.D.
Phone
+86-20-87343469
Email
majun2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Kaibin Yang, M.D.
Phone
+86-13725368062
Email
yangkb@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ma, M.D.
Phone
+862087343469
Email
majun2@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients
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