NCT06494800

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 2, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

PET-CTlung cancer

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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.

    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

    1 Year

Secondary Outcomes (3)

  • assessment of the pleural thickening/effusion associated with the primary mass

    1 Year

  • presence of enlarged axillary Lns

    1 Year

  • assessing the Vocal cord paralysis in the pan-coast tumor

    1 Year

Study Arms (1)

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.

Diagnostic Test: True cut needle biobsy

Interventions

True cut needle biobsyDIAGNOSTIC_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.

Also known as: TCNB
pathologically proved lung cancer patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the pathologically proved lung cancer patient in the oncology department at the sohag oncology Centre.

You may qualify if:

  • Pathologically proven lung cancer patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 35815631BACKGROUND
  • 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.

    PMID: 38455708BACKGROUND
  • Panunzio A, Sartori P. Lung Cancer and Radiological Imaging. Curr Radiopharm. 2020;13(3):238-242. doi: 10.2174/1874471013666200523161849.

    PMID: 32445458BACKGROUND
  • 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.

    PMID: 35738910BACKGROUND

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • mai sayed khalifa, MD

    lecturer

    PRINCIPAL INVESTIGATOR
  • doaa ibrahim mohamed, MD

    lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mennatallah ahmed raghib, M.B.B.Ch

CONTACT

wafaa abdelhamid elsayed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident, nuclear and oncology medicine department, Sohag university

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

July 15, 2024

Primary Completion

July 15, 2025

Study Completion

December 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07