NCT04928560

Brief Summary

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.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

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

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 16, 2021

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

April 7, 2021

Last Update Submit

June 9, 2021

Conditions

LymphadenopathyULTRASOUND

Outcome Measures

Primary Outcomes (1)

  • PATHOLOGY

    BIOPSY/SURGERY

    up to 3 months

Study Arms (2)

disease free survival

disease free survival

Diagnostic Test: SMI

non-disease free survival

non-disease free survival

Diagnostic Test: SMI

Interventions

SMIDIAGNOSTIC_TEST

ULTRASOUND

Also known as: CEUS
disease free survivalnon-disease free survival

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with lymphadenopathy

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZJU

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lymphadenopathy

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • pintong Huang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

June 16, 2021

Study Start

September 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2022

Last Updated

June 16, 2021

Record last verified: 2020-09

Locations

CN(1)