Positron-Emission TomographyNCT03830242
Diagnostic Significance of FDG PET/CT Dynamic Imaging in Detecting Metastatic Lymph Nodes With Papillary Thyroid Cancer.
A study testing <Sup>18<Sup>F-FDG PET/CT dynamic scan and B-ultrasonography in people with Positron-Emission Tomography and Lymph Node Metastases, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The aim of this study is to make up for the gap by performing a dynamic scan of <Sup>18<Sup>F-FDG PET/CT on newly diagnosed patients with papillary thyroid carcinoma. Pathological and genomic studies are performed. The differences between metastatic central lymph nodes images and tissues are compared at the same time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Positron-Emission Tomography, Lymph Node Metastases, Thyroid Cancer
- What is being tested?
- <Sup>18<Sup>F-FDG PET/CT dynamic scan and B-ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Accurately diagnosing primary papillary thyroid cancer according to pathological diagnostic criteria .
- Thyroid papillary carcinoma was suspected by thyroid ultrasound text and/or neck CT.
- The age is more than 18 years old and less than 65 years old. There is no gender restriction.
- Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy.
- Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min.
- Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent.
Who cannot join
- • Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL).• In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women.
- Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.).
- Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate.
- People with severe emphysema, pulmonary congestion, and pulmonary heart disease.
- Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Hongjun JIN, doctor, 0756-2526136, jinhj3@mail.sysu.edu.cn
About this study
Official title: Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging in Detecting Metastatic Central Lymph Nodes in Patients With Papillary Thyroid Cancer
The aim of this study is to make up for the gap by performing a dynamic scan of <Sup>18<Sup>F-FDG PET/CT on newly diagnosed patients with papillary thyroid carcinoma. Pathological and genomic studies are performed. The differences between metastatic central lymph nodes images and tissues are compared at the same time. <Sup>18<Sup>F-FDG PET/CT dynamic imaging is explored in metastatic central lymph nodes with papillary thyroid cancer for the diagnostic value.
Read the detailed description
Thyroid cancer is the most common malignant tumor in human endocrine system, accounting for 0.2% ~ 1.0% of malignant tumors .According to the global cancer report released by the world health organization (WHO) in 2014, 50% of the new cases of thyroid cancer are papillary thyroid cancer (PTC). In recent years, the incidence of thyroid cancer in China shows an increasing trend, especially the composition ratio of thyroid micro-papillary carcinoma with the focal diameter <1 cm increases rapidly.Although PTC has a good prognosis, according to a Meta analysis , PTC lymph node metastasis rate is as high as 28.0%.The central lymph node is the most common metastatic site of papillary thyroid carcinoma.In addition, it has been reported in literature that lymph nodes in the central region are the first stop of thyroid papillary carcinoma metastasis (i.e., sentinel lymph nodes), and lymph nodes metastatic to this point are prone to infringe the peripheral esophagus, trachea and recurrent laryngeal nerve at an early stage.A large number of clinical cases have confirmed that lymph node metastasis of thyroid cancer significantly increases the local recurrence rate after surgery.More studies have shown that regional lymph node metastasis increases mortality.Therefore, the treatment of lymph node metastasis should not be ignored in PTC patients.However, at present, preoperative imaging has certain limitations in the judgment of lymph node metastasis in the central region : ultrasound has advantages in the judgment of lymph node metastasis in the peripheral group, but poor display in the central group.Although MRI scan of head and neck can be multi-directional and multi-sequence imaging, and the resolution of soft tissue is high, it is not good at showing calcification.Conventional CT alone based on lymph node morphology to determine metastasis also has some limitations;Positron emission tomography (PET) sensitivity was < 40%.Although one study showed that the probability of non-missed diagnosis of lymph nodes in central PTC region by thin slice CT scan was 100%, the specificity was low and the study was retrospective.Therefore, b-ultrasound, MRI, CT, PET and other auxiliary examinations have not been able to effectively detect all central metastatic lymph nodes before surgery.For management of cervical lymph nodes ,2015 American Thyroid Association（ATA） guidelines show that thyroid+therapeutic Ⅵ area lymph node dissection should be undertaken if in central or lateral lymph nodes are involved.Chinese guidelines recommend that, in order to avoid operative complications as far as possible (i.e. effective retainment of the parathyroid gland and recurrent laryngeal nerve), regardless of the size of the primary thyroid lesion, lymph node dissection in the central area on the same side of the lesion should be performed at least.However, in 2017, the second edition of National Comprehensive Cancer Network(NCCN) thyroid tumor guidelines believed that if lymph nodes in the central region were negative, preventive central region lymph node dissection was not recommended.Above all，there is so much controversy over lymph node dissection in the central region. Therefore，it is of great significance to effectively evaluate the preoperative lymph nodes station in the central region of thyroid papillary carcinoma.
Early dynamic imaging examination of <Sup>18<Sup>F-FDG PET/CT can be defined as a imaging method to detect the status of radioactive tracer (<Sup>18<Sup>F-FDG) which travels with the blood flow and is continuously absorbed and excreted by organs (or diseased) tissues after being introduced into the body in the early stage.This development reflects the change of <Sup>18<Sup>F-FDG activity with time in the early stage of entering the body, and can provide information about the dynamic change of tracer metabolism and distribution in tissues with time, so that it can provide more metabolic and distribution details of tumor lesions and metastatic lesions than static scanning.At present, many studies have shown that <Sup>18<Sup>F-FDG PET/CT early dynamic imaging technology can effectively improve the sensitivity of hepatocellular carcinoma ,renal cell carcinoma and other tumors.More amazing，there may be more advantages in evaluating lymph node metastasis.The blood supply of lymph nodes metastatic of thyroid papillary carcinoma is abundant, which helps to locate the metastatic tumor lymph node.However，there is no relevant study.Now , investigators plan to observe the significance of the method to evaluate the central lymph node metastasis in thyroid papillary carcinoma as well as the intrinsic correlations between the significance and postoperative pathological results ,which may help to develop surgical strategy by preoperative evaluation and avoiding additional dissection.
- Being tested
- <Sup>18<Sup>F-FDG PET/CT dynamic scan, B-ultrasonography
- Medical subject headings
- Lymphatic Metastasis, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
<Sup>18<Sup>F-FDG PET/CT dynamic scanDiagnostic test
The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
B-ultrasonographyDiagnostic test
The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
| Study group | Role | What they receive |
|---|---|---|
| <Sup>18<Sup>F-FDG PET/CT study group | Experimental | <Sup>18<Sup>F-FDG PET/CT dynamic scan,Pathological examination and gene detection Diagnostic Test: <Sup>18<Sup>F-FDG PET/CT dynamic scan The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed. Receives: Diagnostic Test: <Sup>18<Sup>F-FDG PET/CT dynamic scan |
| B-ultrasonography group | Other | B-ultrasonography,Pathological examination and gene detection Diagnostic Test:B-ultrasonography The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed. Receives: Diagnostic Test: B-ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lymph nodes dissected
Count the number of lymph nodes dissected during operation of every Participants.
Measured: 12 months
Number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.
Count the number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.
Measured: 12 months
Number of Participants diagnosed with lymph node metastasis by Postoperative pathology
Count the number of Participants diagnosed with lymph node metastasis by Postoperative pathology.
Measured: 12 months
The number of lymph node metastases in patients with different Genetic types
To count the number of lymph node metastases in patients with different Genetic types basing on genetic testing.
Measured: 12 months
Secondary outcomes (4)
Calculating the overall diagnostic sensitivity of <Sup>18<Sup>F-FDG PET/CT dynamic scans
Calculating the overall diagnostic sensitivity based on the results of <Sup>18<Sup>F-FDG PET/CT dynamic scans and Postoperative pathology.
Measured: 12 months
Calculating the overall diagnostic specificity of <Sup>18<Sup>F-FDG PET/CT dynamic scans
Calculating the overall diagnostic specificity based on the results of <Sup>18<Sup>F-FDG PET/CT dynamic scans and Postoperative pathology.
Measured: 12 months
Calculating the receiver operating characteristic curve（ROC）
Calculate receiver operating characteristic curve（ROC） based on sensitivity and specificity.
Measured: 12 months
Calculating the radionics indicators of <Sup>18<Sup>F-FDG PET/CT
Based on the results above,to calculate the radionics indicators of <Sup>18<Sup>F-FDG PET/CT dynamic scans in detecting metastatic central lymph nodes in participants with papillary thyroid cancer .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Nov 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron-Emission TomographyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongjun Jin, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830242
- Sponsor's protocol ID
- ZDWY.JRWK.001
- Status last verified
- Jul 2022
- First submitted
- 17 Dec 2018
- Last updated
- 28 Jul 2022
- 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 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging in Detecting Metastatic Central Lymph Nodes in Patients With Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03830242
- Acronym / sponsor ID
- ZDWY.JRWK.001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 2019 (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 aim of this study is to make up for the gap by performing a dynamic scan of <Sup>18<Sup>F-FDG PET/CT on newly diagnosed patients with papillary thyroid carcinoma. Pathological and genomic studies are performed. The differences between metastatic central lymph nodes images and tissues are compared at the same time. <Sup>18<Sup>F-FDG PET/CT dynamic imaging is explored in metastatic central lymph nodes with papillary thyroid cancer for the diagnostic value.
Detailed description
Thyroid cancer is the most common malignant tumor in human endocrine system, accounting for 0.2% ~ 1.0% of malignant tumors .According to the global cancer report released by the world health organization (WHO) in 2014, 50% of the new cases of thyroid cancer are papillary thyroid cancer (PTC). In recent years, the incidence of thyroid cancer in China shows an increasing trend, especially the composition ratio of thyroid micro-papillary carcinoma with the focal diameter <1 cm increases rapidly.Although PTC has a good prognosis, according to a Meta analysis , PTC lymph node metastasis rate is as high as 28.0%.The central lymph node is the most common metastatic site of papillary thyroid carcinoma.In addition, it has been reported in literature that lymph nodes in the central region are the first stop of thyroid papillary carcinoma metastasis (i.e., sentinel lymph nodes), and lymph nodes metastatic to this point are prone to infringe the peripheral esophagus, trachea and recurrent laryngeal nerve at an early stage.A large number of clinical cases have confirmed that lymph node metastasis of thyroid cancer significantly increases the local recurrence rate after surgery.More studies have shown that regional lymph node metastasis increases mortality.Therefore, the treatment of lymph node metastasis should not be ignored in PTC patients.However, at present, preoperative imaging has certain limitations in the judgment of lymph node metastasis in the central region : ultrasound has advantages in the judgment of lymph node metastasis in the peripheral group, but poor display in the central group.Although MRI scan of head and neck can be multi-directional and multi-sequence imaging, and the resolution of soft tissue is high, it is not good at showing calcification.Conventional CT alone based on lymph node morphology to determine metastasis also has some limitations;Positron emission tomography (PET) sensitivity was < 40%.Although one study showed that the probability of non-missed diagnosis of lymph nodes in central PTC region by thin slice CT scan was 100%, the specificity was low and the study was retrospective.Therefore, b-ultrasound, MRI, CT, PET and other auxiliary examinations have not been able to effectively detect all central metastatic lymph nodes before surgery.For management of cervical lymph nodes ,2015 American Thyroid Association（ATA） guidelines show that thyroid+therapeutic Ⅵ area lymph node dissection should be undertaken if in central or lateral lymph nodes are involved.Chinese guidelines recommend that, in order to avoid operative complications as far as possible (i.e. effective retainment of the parathyroid gland and recurrent laryngeal nerve), regardless of the size of the primary thyroid lesion, lymph node dissection in the central area on the same side of the lesion should be performed at least.However, in 2017, the second edition of National Comprehensive Cancer Network(NCCN) thyroid tumor guidelines believed that if lymph nodes in the central region were negative, preventive central region lymph node dissection was not recommended.Above all，there is so much controversy over lymph node dissection in the central region. Therefore，it is of great significance to effectively evaluate the preoperative lymph nodes station in the central region of thyroid papillary carcinoma.
Early dynamic imaging examination of <Sup>18<Sup>F-FDG PET/CT can be defined as a imaging method to detect the status of radioactive tracer (<Sup>18<Sup>F-FDG) which travels with the blood flow and is continuously absorbed and excreted by organs (or diseased) tissues after being introduced into the body in the early stage.This development reflects the change of <Sup>18<Sup>F-FDG activity with time in the early stage of entering the body, and can provide information about the dynamic change of tracer metabolism and distribution in tissues with time, so that it can provide more metabolic and distribution details of tumor lesions and metastatic lesions than static scanning.At present, many studies have shown that <Sup>18<Sup>F-FDG PET/CT early dynamic imaging technology can effectively improve the sensitivity of hepatocellular carcinoma ,renal cell carcinoma and other tumors.More amazing，there may be more advantages in evaluating lymph node metastasis.The blood supply of lymph nodes metastatic of thyroid papillary carcinoma is abundant, which helps to locate the metastatic tumor lymph node.However，there is no relevant study.Now , investigators plan to observe the significance of the method to evaluate the central lymph node metastasis in thyroid papillary carcinoma as well as the intrinsic correlations between the significance and postoperative pathological results ,which may help to develop surgical strategy by preoperative evaluation and avoiding additional dissection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <Sup>18<Sup>F-FDG PET/CT study group | Experimental | Diagnostic Test: <Sup>18<Sup>F-FDG PET/CT dynamic scan<Sup>18<Sup>F-FDG PET/CT dynamic scan,Pathological examination and gene detection Diagnostic Test: <Sup>18<Sup>F-FDG PET/CT dynamic scan The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed. |
| B-ultrasonography group | Other | Diagnostic Test: B-ultrasonographyB-ultrasonography,Pathological examination and gene detection Diagnostic Test:B-ultrasonography The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Accurately diagnosing primary papillary thyroid cancer according to pathological diagnostic criteria .
Key exclusion criteria (5 listed)
- • Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL).• In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women.
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 |
|---|---|---|
| <Sup>18<Sup>F-FDG PET/CT dynamic scanThe purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed. | Diagnostic test | <Sup>18<Sup>F-FDG PET/CT study group |
| B-ultrasonographyThe purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed. | Diagnostic test | B-ultrasonography group |
Primary outcome
Number of lymph nodes dissected
Time frame: 12 months
Count the number of lymph nodes dissected during operation of every Participants.
Number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.
Time frame: 12 months
Count the number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.
Number of Participants diagnosed with lymph node metastasis by Postoperative pathology
Time frame: 12 months
Count the number of Participants diagnosed with lymph node metastasis by Postoperative pathology.
The number of lymph node metastases in patients with different Genetic types
Time frame: 12 months
To count the number of lymph node metastases in patients with different Genetic types basing on genetic testing.
4 secondary outcomes
Calculating the overall diagnostic sensitivity of <Sup>18<Sup>F-FDG PET/CT dynamic scans
Time frame: 12 months
Calculating the overall diagnostic specificity of <Sup>18<Sup>F-FDG PET/CT dynamic scans
Time frame: 12 months
Calculating the receiver operating characteristic curve（ROC）
Time frame: 12 months
Calculating the radionics indicators of <Sup>18<Sup>F-FDG PET/CT
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing <Sup>18<Sup>F-FDG PET/CT dynamic scan and B-ultrasonography in people with Positron-Emission Tomography and Lymph Node Metastases, 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 6 inclusion and 5 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 28 Jul 2022. 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, doctor (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?
Number of lymph nodes dissected (time frame: 12 months). 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 28 Jul 2022.