Positron-Emission TomographyNCT03679936
Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions and Differentiating Multiple Primary Lung Cancer From Intrapulmonary Metastases of Non-small Cell Lung Cancer
An observational study of Positron-Emission Tomography and Non-small Cell Lung Cancer, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in metastasis of non-small cell lung cancer (NSCLC). The investigators will collect dynamic 18F-FDG PET/CT scan and correlate the imaging findings with genomics and histopathological features of biopsy of primary or / and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Positron-Emission Tomography, Non-small Cell Lung Cancer
- What is being tested?
- PET/CT dynamic scan
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2018to 31 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: More than 18 years old and less than 65 years old, no gender limitation, first diagnosis of non-small cell lung cancer patients, patients who must comply with all the inclusion criteria are eligible to participate in this study.However,patients who meet any of the exclusion criteria will not be eligible to participate in this study.
Who may be able to join
- Accurately diagnosing primary liver cancer according to pathological diagnostic criteria or clinical diagnostic criteria.
- Tumor volume (> 1 cm) displayed by enhanced CT or MRI or liver mass confirmed by arteriography .
- For patients considering distant metastases, trunk metastases need to be confirmed by CT examination. Bone metastases need to be confirmed by whole-body bone scan. Brain metastases need to be confirmed with characteristic metastatic tumors by MRI.
- 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 ECOG: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64kPa; 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
Hongjun Jin
Zhuhai, Guangzhou, 519000
Jin, 0756-2526136, jinhj3@mail.sysu.edu.cn
Hongjun Jin, PhD.
About this study
The purpose of this study is to evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in metastasis of non-small cell lung cancer (NSCLC). The investigators will collect dynamic 18F-FDG PET/CT scan and correlate the imaging findings with genomics and histopathological features of biopsy of primary or / and metastatic lesions in patients with newly diagnosed non-small cell lung cancer (NSCLC). At the same time, the investigators will evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in differentiating multiple primary lung cancer from intrapulmonary metastases.
Read the detailed description
Lung cancer is a malignant tumor with the highest morbidity and mortality in China and all over the world, in which non-small cell lung cancer (NSCLC) accounts for more than 85% of all categories [1-2]. Although the precision medicine has greatly improved the survival time of patients with NSCLC, most patients still have recurrence and metastasis after a period of time [3]. The nature of tumorigenesis, development and metastasis is a series of biochemical processes, such as abnormal gene expression and metabolism, dysfunction and structural change. Early prediction of tumor metastasis and accurate and timely clinical intervention will not only help clinicians to formulate treatment plans, but also reduce unnecessary side effects and medical expenses with ineffective treatment. 18F-FDG-PET scans can reflect metabolic changes at cellular and molecular level, and the metabolic information are transmitted earlier than anatomical changes. Detection of 18F-FDG uptake, analysis of tumor metabolism, tissue blood flow perfusion, receptor, and so on, can provide a theoretical basis for monitoring the therapeutic efficacy of lung cancer by PET [4].
As a new imaging technique, 18F-FDG PET/CT plays a more and more important role in the diagnosis of tumor. 18F-FDG PET/CT reflects the process of glucose metabolism in tumor tissue. The diagnosis of benign and malignant tumors is based on the difference of glucose metabolism activity between tumor cells and normal tissue cells. 18F-FDG is the isomer of glucose, which participates in the process of glucose metabolism. Because it cannot produce hexose diphosphate because of its deoxidation, it cannot participate in the next metabolism, and it is retained in cells. Due to the high expression of glucose transport mRNA,the level of Glut-1 and Glut-3 increased, the expression of hexokinase increased, and the level of glucose-6-phosphatase decreased, which resulted in an increase of 18F-FDG uptake in tumor cells [5]. Molecular imaging using 18F-FDG PET / CT can provide metabolic information, which can make benign and malignant tissues differentiate better, and reveal the functional abnormalities before structural damage [6]. However, the current PET/CT scans reported in the relevant literature are based on conventional static scans, i.e. the image data is based on a static take-up image of the tracer in tissue obtained at a fixed time point after the injection of 18F-FDG. To improve, the investigators propose to use dynamic data scanning, which captures the dynamic data of whole body tissues collected from the moment of injecting 18F-FDG to an hour. Dynamic scans can provide information on the dynamic changes in tracer metabolism and distribution in tissues over time, so they provide a richer metabolic and distributional pattern of tumor foci and metastases than static scans. Therefore, the aim of this study is to make up for this gap by performing a dynamic scan of 18F-FDG PET/CT on newly diagnosed patients with non-small cell lung cancer. The lesions and/or metastases are performed for biopsy. Pathological and genomic studies are performed. The differences between tumor images and tissues are compared at the same time. 18F-FDG PET/CT dynamic imaging is explored in non-small cell lung cancer metastases for the diagnostic value.At the same time, the ability to differentiate multiple primary lung cancer from intrapulmonary metastases of 18F-FDG PET/CT dynamic imaging will be dissussed .
- Being tested
- PET/CT dynamic scan
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT dynamic scanDiagnostic test
Also called Needle biopsy, Gene detection
This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
| Study group | Role | What they receive |
|---|---|---|
| Non-metastatic group | PET/CT dynamic scan,needle biopsy and gene detection Receives: Diagnostic Test: PET/CT dynamic scan | |
| Metastatic group | PET/CT dynamic scan,needle biopsy and gene detection Receives: Diagnostic Test: PET/CT dynamic scan | |
| Multiple primary lung cancer group | PET/CT dynamic scan,needle biopsy and gene detection Receives: Diagnostic Test: PET/CT dynamic scan | |
| Intrapulmonary metastases group | PET/CT dynamic scan,needle biopsy and gene detection Receives: Diagnostic Test: PET/CT dynamic scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculating the overall diagnostic sensitivity and specificity and ROC
For each patient enrolled in the study, a two-chamber four-parameter model (2TCM) and a Patlak two-parameter model are established using 18F-FDG PET/CT dynamic scans. Summarizing these dynamic model parameters for all enrolled patients separately calculates the overall diagnostic sensitivity and specificity. Calculate ROC based on sensitivity and specificity.
Measured: 60 minutes
Secondary outcomes (1)
Calculating the overall diagnostic sensitivity and specificity and summarizing the intrinsic correlation
Summarize the genetic testing of all enrolled patients and radiomic indicators to calculate the overall diagnostic sensitivity and specificity. At the same time, the intrinsic correlations between genomics, gene detection and histopathology are summarized.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start3 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679936
- Sponsor's protocol ID
- ZDWY.FZYX.002
- Status last verified
- Apr 2022
- First submitted
- 19 Sep 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang M, Lin Z, Xu Z, Li D, Lv W, Yang S, Liu Y, Cao Y, Cao Q, Jin H. Influx rate constant of 18F-FDG increases in metastatic lymph nodes of non-small cell lung cancer patients. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1198-1208. doi: 10.1007/s00259-020-04682-5. Epub 2020 Jan 23.
PubMed 31974680
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 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 and Genomic Sequencing in Detecting Metastatic Lesions and Differentiating Multiple Primary Lung Cancer From Intrapulmonary Metastases of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03679936
- Acronym / sponsor ID
- ZDWY.FZYX.002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2018 (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 evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in metastasis of non-small cell lung cancer (NSCLC). The investigators will collect dynamic 18F-FDG PET/CT scan and correlate the imaging findings with genomics and histopathological features of biopsy of primary or / and metastatic lesions in patients with newly diagnosed non-small cell lung cancer (NSCLC). At the same time, the investigators will evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in differentiating multiple primary lung cancer from intrapulmonary metastases.
Detailed description
Lung cancer is a malignant tumor with the highest morbidity and mortality in China and all over the world, in which non-small cell lung cancer (NSCLC) accounts for more than 85% of all categories [1-2]. Although the precision medicine has greatly improved the survival time of patients with NSCLC, most patients still have recurrence and metastasis after a period of time [3]. The nature of tumorigenesis, development and metastasis is a series of biochemical processes, such as abnormal gene expression and metabolism, dysfunction and structural change. Early prediction of tumor metastasis and accurate and timely clinical intervention will not only help clinicians to formulate treatment plans, but also reduce unnecessary side effects and medical expenses with ineffective treatment. 18F-FDG-PET scans can reflect metabolic changes at cellular and molecular level, and the metabolic information are transmitted earlier than anatomical changes. Detection of 18F-FDG uptake, analysis of tumor metabolism, tissue blood flow perfusion, receptor, and so on, can provide a theoretical basis for monitoring the therapeutic efficacy of lung cancer by PET [4].
As a new imaging technique, 18F-FDG PET/CT plays a more and more important role in the diagnosis of tumor. 18F-FDG PET/CT reflects the process of glucose metabolism in tumor tissue. The diagnosis of benign and malignant tumors is based on the difference of glucose metabolism activity between tumor cells and normal tissue cells. 18F-FDG is the isomer of glucose, which participates in the process of glucose metabolism. Because it cannot produce hexose diphosphate because of its deoxidation, it cannot participate in the next metabolism, and it is retained in cells. Due to the high expression of glucose transport mRNA,the level of Glut-1 and Glut-3 increased, the expression of hexokinase increased, and the level of glucose-6-phosphatase decreased, which resulted in an increase of 18F-FDG uptake in tumor cells [5]. Molecular imaging using 18F-FDG PET / CT can provide metabolic information, which can make benign and malignant tissues differentiate better, and reveal the functional abnormalities before structural damage [6]. However, the current PET/CT scans reported in the relevant literature are based on conventional static scans, i.e. the image data is based on a static take-up image of the tracer in tissue obtained at a fixed time point after the injection of 18F-FDG. To improve, the investigators propose to use dynamic data scanning, which captures the dynamic data of whole body tissues collected from the moment of injecting 18F-FDG to an hour. Dynamic scans can provide information on the dynamic changes in tracer metabolism and distribution in tissues over time, so they provide a richer metabolic and distributional pattern of tumor foci and metastases than static scans. Therefore, the aim of this study is to make up for this gap by performing a dynamic scan of 18F-FDG PET/CT on newly diagnosed patients with non-small cell lung cancer. The lesions and/or metastases are performed for biopsy. Pathological and genomic studies are performed. The differences between tumor images and tissues are compared at the same time. 18F-FDG PET/CT dynamic imaging is explored in non-small cell lung cancer metastases for the diagnostic value.At the same time, the ability to differentiate multiple primary lung cancer from intrapulmonary metastases of 18F-FDG PET/CT dynamic imaging will be dissussed .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-metastatic group | – | Diagnostic Test: PET/CT dynamic scanPET/CT dynamic scan,needle biopsy and gene detection |
| Metastatic group | – | Diagnostic Test: PET/CT dynamic scanPET/CT dynamic scan,needle biopsy and gene detection |
| Multiple primary lung cancer group | – | Diagnostic Test: PET/CT dynamic scanPET/CT dynamic scan,needle biopsy and gene detection |
| Intrapulmonary metastases group | – | Diagnostic Test: PET/CT dynamic scanPET/CT dynamic scan,needle biopsy and gene detection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- More than 18 years old and less than 65 years old, no gender limitation, first diagnosis of non-small cell lung cancer patients, patients who must comply with all the inclusion criteria are eligible to participate in this study.However,patients who meet any of the exclusion criteria will not be eligible to participate in this study.
Key inclusion criteria (7 listed)
- Accurately diagnosing primary liver cancer according to pathological diagnostic criteria or clinical diagnostic criteria.
- Tumor volume (> 1 cm) displayed by enhanced CT or MRI or liver mass confirmed by arteriography .
- For patients considering distant metastases, trunk metastases need to be confirmed by CT examination. Bone metastases need to be confirmed by whole-body bone scan. Brain metastases need to be confirmed with characteristic metastatic tumors by MRI.
- 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.
Key exclusion criteria (7 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.
- 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.
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 |
|---|---|---|
| PET/CT dynamic scanAlso: Needle biopsy, Gene detectionThis study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases. | Diagnostic test | Intrapulmonary metastases group, Metastatic group, Multiple primary lung cancer group, Non-metastatic group |
Primary outcome
Calculating the overall diagnostic sensitivity and specificity and ROC
Time frame: 60 minutes
For each patient enrolled in the study, a two-chamber four-parameter model (2TCM) and a Patlak two-parameter model are established using 18F-FDG PET/CT dynamic scans. Summarizing these dynamic model parameters for all enrolled patients separately calculates the overall diagnostic sensitivity and specificity. Calculate ROC based on sensitivity and specificity.
1 secondary outcome
Calculating the overall diagnostic sensitivity and specificity and summarizing the intrinsic correlation
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 31974680Yang M, Lin Z, Xu Z, Li D, Lv W, Yang S, Liu Y, Cao Y, Cao Q, Jin H. Influx rate constant of 18F-FDG increases in metastatic lymph nodes of non-small cell lung cancer patients. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1198-1208. doi: 10.1007/s00259-020-04682-5. Epub 2020 Jan 23.
- 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?
An observational study of Positron-Emission Tomography and Non-small Cell Lung Cancer, 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 7 inclusion and 7 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 25 Apr 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 Jin (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?
Calculating the overall diagnostic sensitivity and specificity and ROC (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679936, which also lists 1 linked publication.
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 25 Apr 2022.