LymphadenopathyNCT04928560
Diagnosis of Superficial Lymphadenopathy
An observational study of Lymphadenopathy and ULTRASOUND, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphadenopathy, ULTRASOUND
- What is being tested?
- SMI
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lymphadenopathy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphadenopathy, ULTRASOUND
- Being tested
- SMI
- Medical subject headings
- Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMIDiagnostic test
Also called CEUS
ULTRASOUND
| Study group | Role | What they receive |
|---|---|---|
| disease free survival | disease free survival Receives: Diagnostic Test: SMI | |
| non-disease free survival | non-disease free survival Receives: Diagnostic Test: SMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PATHOLOGY
BIOPSY/SURGERY
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Sep 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- pintong Huang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928560
- Sponsor's protocol ID
- 2020-588
- Status last verified
- Sep 2020
- First submitted
- 7 Apr 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMI and CEUS in the Diagnosis of Superficial Lymphadenopathy
- ClinicalTrials.gov ID
- NCT04928560
- Acronym / sponsor ID
- 2020-588
- Conditions
- Lymphadenopathy, ULTRASOUND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 16 Jun 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| disease free survival | – | Diagnostic Test: SMIdisease free survival |
| non-disease free survival | – | Diagnostic Test: SMInon-disease free survival |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lymphadenopathy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- The patient's position cannot be matched during ultrasound examination
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 |
|---|---|---|
| SMIAlso: CEUSULTRASOUND | Diagnostic test | disease free survival, non-disease free survival |
Primary outcome
PATHOLOGY
Time frame: up to 3 months
BIOPSY/SURGERY
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
pintong Huang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphadenopathy and ULTRASOUND, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 2 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 16 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PATHOLOGY (time frame: up to 3 months). 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 16 Jun 2021.