Clinical trial NCT06494800: Added Value of PET/CT in Lung Cancer
Official title: Added Value of 18F-FDG PET/CT in Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: PET-CT
lung cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the pathologically proved lung cancer patient in the oncology department at the sohag oncology Centre.

Brief summary: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of PET CT in diagnosis of lung cancer
timeFrame: 1 Year
measure: Value of PET CT in staging of lung cancer
timeFrame: 1 Year
measure: predicting the pathological subtype of lung cancer using the morphological and PET CT of pathologically proved lung masses
timeFrame: 1 Year
measure: Differentiating between the primary mass and associated consolidation if present
timeFrame: 1 Year
Secondary outcomes:
measure: assessment of the pleural thickening/effusion associated with the primary mass
timeFrame: 1 Year
measure: presence of enlarged axillary Lns
timeFrame: 1 Year
measure: assessing the Vocal cord paralysis in the pan-coast tumor
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: lecturer
name: mai sayed khalifa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer
name: doaa ibrahim mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Laguna 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.
citation: Panunzio A, Sartori P. Lung Cancer and Radiological Imaging. Curr Radiopharm. 2020;13(3):238-242. doi: 10.2174/1874471013666200523161849.
citation: Kandathil 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.