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NCT Number: NCT06494800

Added Value of PET/CT in Lung Cancer

Assess the value of PET/CT in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically proven lung cancer patients.

Exclusion criteria

  • 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.

Treatment and study plan

True cut needle biobsy

Diagnostic Test

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.

Other names: TCNB

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

Secondary outcomes

  1. assessment of the pleural thickening/effusion associated with the primary mass

    Time frame: 1 Year

    assessing the qualitative and quantitative assessing the pleural thickening if found for differentiating the pleural involvement from the inflammatory pleural thickening

  2. presence of enlarged axillary Lns

    Time frame: 1 Year

    assessing the activity of enlarged axillary Lns by measuring the SUV value

  3. assessing the Vocal cord paralysis in the pan-coast tumor

    Time frame: 1 Year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

mennatallah ahmed raghib, M.B.B.Ch

CONTACT

[email protected]

01115499811

wafaa abdelhamid elsayed, MD

CONTACT

[email protected]

01113111278

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Added Value of 18F-FDG PET/CT in Lung Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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