NCT06520189

Brief Summary

To detect value of F-18FDG PET/CT as a non-invasive method for the prediction of EGFR mutations in lung cancer patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
29mo left

Started Oct 2024

Longer than P75 for all trials

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

Study Progress41%
Oct 2024Oct 2028

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

July 20, 2024

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • • Assessment of semi-quantitative F-18 FDG PET/CT as a non-invasive method for prediction of EGFR mutations in lung cancer patients.

    detection value of F-18 FDG PET/CT for the prediction of EGFR mutation in lung cancer patients.

    baseline

Secondary Outcomes (1)

  • • Assessment of the relationship between degree of the tracer uptake and pathology of the lesion.

    baseline

Interventions

F-18 FDGPET/CT oncology protocol for lung cancer patients

Eligibility Criteria

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

All patients with NSCLC who are ≥ 18 years and underwent EGFR mutation testing and not treated before F-18FDG PET/CT study.

You may qualify if:

  • NSCLC patients who underwent EGFR mutation testing.
  • All patients ≥ 18 years.

You may not qualify if:

  • Time interval between EGFR sampling and PET/CT more than 1 month.
  • Patients had been treated before sampling for the gene alteration analysis
  • Patients with glucose level \< 200 mg/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bade BC, Dela Cruz CS. Lung Cancer 2020: Epidemiology, Etiology, and Prevention. Clin Chest Med. 2020 Mar;41(1):1-24. doi: 10.1016/j.ccm.2019.10.001.

    PMID: 32008623BACKGROUND
  • Harrison PT, Vyse S, Huang PH. Rare epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer. Semin Cancer Biol. 2020 Apr;61:167-179. doi: 10.1016/j.semcancer.2019.09.015. Epub 2019 Sep 25.

    PMID: 31562956BACKGROUND
  • Lv Z, Fan J, Xu J, Wu F, Huang Q, Guo M, Liao T, Liu S, Lan X, Liao S, Geng W, Jin Y. Value of 18F-FDG PET/CT for predicting EGFR mutations and positive ALK expression in patients with non-small cell lung cancer: a retrospective analysis of 849 Chinese patients. Eur J Nucl Med Mol Imaging. 2018 May;45(5):735-750. doi: 10.1007/s00259-017-3885-z. Epub 2017 Nov 21.

    PMID: 29164298BACKGROUND
  • Huang CT, Yen RF, Cheng MF, Hsu YC, Wei PF, Tsai YJ, Tsai MF, Shih JY, Yang CH, Yang PC. Correlation of F-18 fluorodeoxyglucose-positron emission tomography maximal standardized uptake value and EGFR mutations in advanced lung adenocarcinoma. Med Oncol. 2010 Mar;27(1):9-15. doi: 10.1007/s12032-008-9160-1. Epub 2009 Jan 7.

    PMID: 19130320BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

walaa Gamal Fathy, assistant lecturer

CONTACT

Nahla Moustafa Mahmoud, Assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 20, 2024

First Posted

July 25, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

July 25, 2024

Record last verified: 2024-07