Lung CancerNCT06494800
Added Value of PET/CT in Lung Cancer
An observational study of Lung Cancer, run by Sohag University.
Trial summary
Assess the value of PET/CT in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- True cut needle biobsy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the pathologically proved lung cancer patient in the oncology department at the sohag oncology Centre.
Who may be able to join
- Pathologically proven lung cancer patients.
Who cannot join
- Patients with second malignancy.
- Severely ill patient (patient with disturbed consciousness level, or couldn't lie during the imaging).
- Uncontrolled diabetic patient with blood glucose level more than 200mg\dl.
- Pregnant women.
- Patient age <18 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Added Value of 18F-FDG PET/CT in Lung Cancer
Assess the value of PET/CT in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer.
Read the detailed description
Lung cancer is a leading cause of cancer-related mortality worldwide, accounted for 1.80 million deaths in 2020.(1)Egyptian statistics showed that lung cancer in men represents 8.2% of among all cancers of men according to the Egyptian National Cancer Program in 2014 (3).Epidemiological data indicate that the main risk factor for the development of lung cancer is cigarette smoking.(4)Lung cancer is histologically divided into: Non-small-cell lung cancer (NSCLC), which accounts for 85% of cases and Small cell lung cancer (SCLC).(5)Due to absence of screening, most patients with lung cancer are not diagnosed until later stages, when the prognosis is poor.(6)Radiologic manifestations of bronchogenic carcinoma include obstructive pneumonitis or atelectasis, lung nodule or mass, apical mass, cavitated mass, or nodule or mass associated with lymphadenopathy(6)Conventional chest radiography, computed tomography (CT), magnetic resonance imaging, radionuclide scintigraphy, and positron emission tomography (PET) all have been used for NSCLC staging.(7)PET/CT is a well-established radiological modality with high diagnostic accuracy in metastases detection compared to usual CT. Also, it has been reported that up to 10% of patients with bronchogenic carcinoma are found to have metastases on PET/CT that were not detected on CT with subsequent different patients' staging. The high accuracy of PET/CT in tumor staging makes it important for the treatment strategy of either surgical treatment, radiotherapy, or chemotherapy. Also, it becomes essential during the follow-up to detect recurrence. PET/CT shows a higher ability to evaluate the early response to the treatment as chemotherapy by its ability to detect the metabolic response even before the size change.(8)The prognosis of lung tumors depends on early and accurate staging as well as the histopathological type of the primary tumor, with the squamous cell carcinoma type regarded to be of a worse prognosis than that of adenocarcinoma.(9)
- Conditions
- Lung Cancer
- Being tested
- True cut needle biobsy
- Keywords
- PET-CT, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True cut needle biobsyDiagnostic test
Also called TCNB
The biobsy procedure done at the radiology department and the cores are examined by the pathology department, the patient lie prone, supine or in lateral decubitus according to the location of the lesion. A thoracic CT scan was performed first to evaluate the needle pathway and distance from the puncture site to the lesion. The needle pathway was selected to avoid bone, visible vessels, bullae, and fissures. The puncture site was chosen by the CT gantry laser lights and landmarks using a homemade radiopaque grid on the patient's skin. Local anaesthesia was induced with 5 mL of 2% lidocaine. An 18-G coaxial needle was used to puncture the lung, and a repeat CT scan was performed to evaluate the site of the needle. When the needle tip reached the lesion, the specimen was obtained by pressing the trigger of the needle. The specimen was reviewed by the pathologist.The specimen was placed in 10% formaldehyde for pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| pathologically proved lung cancer patient | All the pathologically proved lung cancer patients by true cut needle biobsy are enrolled in the study.
the true cute needle biobsy procedure performed by two interventional radiologists and a pathologist. TCNB was guided by the use of a 16-detector CT device after local anesthesia is done and done either by ultrasound guidance or CT guidance. Receives: Diagnostic Test: True cut needle biobsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of PET CT in diagnosis of lung cancer
using the qualitative and quantitative measuring including the SUV max value in detection of the malignant potentiality of the pulmonary nodule or mass comparing it with the pathological result
Measured: 1 Year
Value of PET CT in staging of lung cancer
using the PET CT in TNM staging with better detection of pleural , mediastinal extension /involvement, the value and accuracy of PET in detecting the potential malignancy of the mediastinal lymph nodes even the subcentemetric lymph nodes not adequately assessed by the usual CT.
Measured: 1 Year
predicting the pathological subtype of lung cancer using the morphological and PET CT of pathologically proved lung masses
assessing the morphology of the lung mass including density, solid, subsolid and soft nodule.
site of the nodule/mass peripheral or centrally located. presence of cavitation or cystic changes. presence of speculated or irregular margin. measuring the SUV max and comparing it with the pathology of each mass/nodule.
Measured: 1 Year
Differentiating between the primary mass and associated consolidation if present
using the PET CT (mainly the qualitative assessment) in differentiating the primary mass from the associated consolidation-atelectasis around
Measured: 1 Year
Secondary outcomes (3)
assessment of the pleural thickening/effusion associated with the primary mass
assessing the qualitative and quantitative assessing the pleural thickening if found for differentiating the pleural involvement from the inflammatory pleural thickening
Measured: 1 Year
presence of enlarged axillary Lns
assessing the activity of enlarged axillary Lns by measuring the SUV value
Measured: 1 Year
assessing the Vocal cord paralysis in the pan-coast tumor
using the morphological assessment of the lower CT neck scans and the adduction of the vocal cord and the atrophic changes of the Muscle and loss of vocal cord physiological activity.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Ahmed Ragheb, Sohag University
- Investigators
- mai sayed khalifa, MD, Principal investigator, lecturerdoaa ibrahim mohamed, MD, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494800
- Sponsor's protocol ID
- PET/CT in lung cancer
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Archer JM, Truong MT, Shroff GS, Godoy MCB, Marom EM. Imaging of Lung Cancer Staging. Semin Respir Crit Care Med. 2022 Dec;43(6):862-873. doi: 10.1055/s-0042-1753476. Epub 2022 Jul 10.
PubMed 35815631Laguna JC, Garcia-Pardo M, Alessi J, Barrios C, Singh N, Al-Shamsi HO, Loong H, Ferriol M, Recondo G, Mezquita L. Geographic differences in lung cancer: focus on carcinogens, genetic predisposition, and molecular epidemiology. Ther Adv Med Oncol. 2024 Mar 6;16:17588359241231260. doi: 10.1177/17588359241231260. eCollection 2024.
PubMed 38455708Panunzio A, Sartori P. Lung Cancer and Radiological Imaging. Curr Radiopharm. 2020;13(3):238-242. doi: 10.2174/1874471013666200523161849.
PubMed 32445458Kandathil A, Subramaniam RM. FDG PET/CT for Primary Staging of Lung Cancer and Mesothelioma. Semin Nucl Med. 2022 Nov;52(6):650-661. doi: 10.1053/j.semnuclmed.2022.04.011. Epub 2022 Jun 20.
PubMed 35738910
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of 18F-FDG PET/CT in Lung Cancer
- ClinicalTrials.gov ID
- NCT06494800
- Acronym / sponsor ID
- PET/CT in lung cancer
- Conditions
- Lung Cancer
- Keywords
- PET-CT, lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Jul 2024 (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.
Assess the value of PET/CT in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer.
Detailed description
Lung cancer is a leading cause of cancer-related mortality worldwide, accounted for 1.80 million deaths in 2020.(1)Egyptian statistics showed that lung cancer in men represents 8.2% of among all cancers of men according to the Egyptian National Cancer Program in 2014 (3).Epidemiological data indicate that the main risk factor for the development of lung cancer is cigarette smoking.(4)Lung cancer is histologically divided into: Non-small-cell lung cancer (NSCLC), which accounts for 85% of cases and Small cell lung cancer (SCLC).(5)Due to absence of screening, most patients with lung cancer are not diagnosed until later stages, when the prognosis is poor.(6)Radiologic manifestations of bronchogenic carcinoma include obstructive pneumonitis or atelectasis, lung nodule or mass, apical mass, cavitated mass, or nodule or mass associated with lymphadenopathy(6)Conventional chest radiography, computed tomography (CT), magnetic resonance imaging, radionuclide scintigraphy, and positron emission tomography (PET) all have been used for NSCLC staging.(7)PET/CT is a well-established radiological modality with high diagnostic accuracy in metastases detection compared to usual CT. Also, it has been reported that up to 10% of patients with bronchogenic carcinoma are found to have metastases on PET/CT that were not detected on CT with subsequent different patients' staging. The high accuracy of PET/CT in tumor staging makes it important for the treatment strategy of either surgical treatment, radiotherapy, or chemotherapy. Also, it becomes essential during the follow-up to detect recurrence. PET/CT shows a higher ability to evaluate the early response to the treatment as chemotherapy by its ability to detect the metabolic response even before the size change.(8)The prognosis of lung tumors depends on early and accurate staging as well as the histopathological type of the primary tumor, with the squamous cell carcinoma type regarded to be of a worse prognosis than that of adenocarcinoma.(9)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pathologically proved lung cancer patient | – | Diagnostic Test: True cut needle biobsyAll the pathologically proved lung cancer patients by true cut needle biobsy are enrolled in the study. the true cute needle biobsy procedure performed by two interventional radiologists and a pathologist. TCNB was guided by the use of a 16-detector CT device after local anesthesia is done and done either by ultrasound guidance or CT guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the pathologically proved lung cancer patient in the oncology department at the sohag oncology Centre.
Key inclusion criteria (1 listed)
- Pathologically proven lung cancer patients.
Key exclusion criteria (5 listed)
- Patients with second malignancy.
- Severely ill patient (patient with disturbed consciousness level, or couldn't lie during the imaging).
- Uncontrolled diabetic patient with blood glucose level more than 200mg\dl.
- Pregnant women.
- Patient age <18 years.
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 |
|---|---|---|
| True cut needle biobsyAlso: TCNBThe biobsy procedure done at the radiology department and the cores are examined by the pathology department, the patient lie prone, supine or in lateral decubitus according to the location of the lesion. A thoracic CT scan was performed first to evaluate the needle pathway and distance from the puncture site to the lesion. The needle pathway was selected to avoid bone, visible vessels, bullae, and fissures. The puncture site was chosen by the CT gantry laser lights and landmarks using a homemade radiopaque grid on the patient's skin. Local anaesthesia was induced with 5 mL of 2% lidocaine. An 18-G coaxial needle was used to puncture the lung, and a repeat CT scan was performed to evaluate the site of the needle. When the needle tip reached the lesion, the specimen was obtained by pressing the trigger of the needle. The specimen was reviewed by the pathologist.The specimen was placed in 10% formaldehyde for pathological examination. | Diagnostic test | pathologically proved lung cancer patient |
Primary outcome
Accuracy of PET CT in diagnosis of lung cancer
Time frame: 1 Year
using the qualitative and quantitative measuring including the SUV max value in detection of the malignant potentiality of the pulmonary nodule or mass comparing it with the pathological result
Value of PET CT in staging of lung cancer
Time frame: 1 Year
using the PET CT in TNM staging with better detection of pleural , mediastinal extension /involvement, the value and accuracy of PET in detecting the potential malignancy of the mediastinal lymph nodes even the subcentemetric lymph nodes not adequately assessed by the usual CT.
predicting the pathological subtype of lung cancer using the morphological and PET CT of pathologically proved lung masses
Time frame: 1 Year
assessing the morphology of the lung mass including density, solid, subsolid and soft nodule. site of the nodule/mass peripheral or centrally located. presence of cavitation or cystic changes. presence of speculated or irregular margin. measuring the SUV max and comparing it with the pathology of each mass/nodule.
Differentiating between the primary mass and associated consolidation if present
Time frame: 1 Year
using the PET CT (mainly the qualitative assessment) in differentiating the primary mass from the associated consolidation-atelectasis around
3 secondary outcomes
assessment of the pleural thickening/effusion associated with the primary mass
Time frame: 1 Year
presence of enlarged axillary Lns
Time frame: 1 Year
assessing the Vocal cord paralysis in the pan-coast tumor
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 35815631Archer JM, Truong MT, Shroff GS, Godoy MCB, Marom EM. Imaging of Lung Cancer Staging. Semin Respir Crit Care Med. 2022 Dec;43(6):862-873. doi: 10.1055/s-0042-1753476. Epub 2022 Jul 10.
- Background: PubMed 38455708Laguna JC, Garcia-Pardo M, Alessi J, Barrios C, Singh N, Al-Shamsi HO, Loong H, Ferriol M, Recondo G, Mezquita L. Geographic differences in lung cancer: focus on carcinogens, genetic predisposition, and molecular epidemiology. Ther Adv Med Oncol. 2024 Mar 6;16:17588359241231260. doi: 10.1177/17588359241231260. eCollection 2024.
- Background: PubMed 32445458Panunzio A, Sartori P. Lung Cancer and Radiological Imaging. Curr Radiopharm. 2020;13(3):238-242. doi: 10.2174/1874471013666200523161849.
- Background: PubMed 35738910Kandathil A, Subramaniam RM. FDG PET/CT for Primary Staging of Lung Cancer and Mesothelioma. Semin Nucl Med. 2022 Nov;52(6):650-661. doi: 10.1053/j.semnuclmed.2022.04.011. Epub 2022 Jun 20.
- Role of CT in differentiation between subtypes of lung cancer; is it possible?Link provided by the sponsor.
- PET-CT in Lung CancerLink provided by the sponsor.
- FDG-PET/CT tumor to liver SUV ratio (TLR), tumor SUVmax, and tumor size: Can this help in differentiating squamous cell carcinoma from adenocarcinoma of the lung?Link provided by the sponsor.
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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.
mai sayed khalifa, MD principal investigator
lecturer
doaa ibrahim mohamed, MD principal investigator
lecturer
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Sohag University.
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 1 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 mennatallah ahmed raghib, M.B.B.Ch (01115499811, menna.ragheb@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of PET CT in diagnosis of lung cancer (time frame: 1 Year). 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?
On the ClinicalTrials.gov record for NCT06494800, which also lists 4 linked publications.
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 10 Jul 2024.