Diagnosis of Superficial Lymphadenopathy

SMI and CEUS in the Diagnosis of Superficial Lymphadenopathy

The purpose of this study is to study the application of CEUS and SMI technology in superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.

Study Overview

• Status: Unknown
• Conditions: Lymphadenopathy; ULTRASOUND
• Intervention / Treatment: Diagnostic test: SMI

Detailed Description

CEUS and SMI technology were used to evaluated the superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • ZJU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with lymphadenopathy

Description

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old;
2. Patients with enlarged lymph nodes detected by ultrasound;
3. No contraindications such as hypersensitivity to contrast-enhanced ultrasound;
4. Voluntarily enrolled in this research project

Exclusion Criteria:

• The patient's position cannot be matched during ultrasound examination

  • Treatment history of lesion area: operation, radiotherapy, intervention, etc ③ Patients without informed consent ④ Lack of clinical data (no effective images such as two-dimensional ultrasound, color Doppler, contrast-enhanced ultrasound, micro blood flow imaging, or poor image quality, unable to analyze, unknown pathological results, etc.) ⑤ Lack of follow up information

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
disease free survival	Diagnostic test: SMI; ULTRASOUND; Other Names: CEUS
non-disease free survival	Diagnostic test: SMI; ULTRASOUND; Other Names: CEUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PATHOLOGY	BIOPSY/SURGERY	up to 3 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pintong Huang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: 2020-588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No