NCT04395651

Brief Summary

Describe strengths and limitations of FDG PET/CT for staging. Evaluate the utility of PET/CT in assessment of therapy response and restaging

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 May 2020

Status
unknown

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 Start

First participant enrolled

May 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 13, 2020

Last Update Submit

May 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • PET/CT in lung cancer

    * Analysis of the number and type of metastatic lesions detected by PET/CT in lung cancer patients(staging). * Analysis of the number and type of metastatic lesions detected by PET/CT in lung cancer patients after therapy(re staging).

    one year

Secondary Outcomes (1)

  • PET/CT in lung cancer

    one year

Interventions

PET/CTDEVICE

It is a prospective clinical study that will include patients known to have lung cancer and referred to nuclear medicine unit to perform 18F-FDG PET/CT for staging and therapy planning as well as patients referred for assessment of response of therapy and restaging.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients during the period of the study will be included (total coverage). Expected number according to patients flow is 30 patients.

You may qualify if:

  • Patients with pathologically proven lung cancer and referred to nuclear medicine unit to perform PET/CT for staging and patient referred for assessment of response of therapy and re staging.

You may not qualify if:

  • Pregnant women.
  • Patients unable to sleep in a fixed position for 20 minutes.
  • Severely ill patients who aren't capable of complying with study procedures or comatose patients.
  • Patients with known second primary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Ambrosini V, Nicolini S, Caroli P, Nanni C, Massaro A, Marzola MC, Rubello D, Fanti S. PET/CT imaging in different types of lung cancer: an overview. Eur J Radiol. 2012 May;81(5):988-1001. doi: 10.1016/j.ejrad.2011.03.020. Epub 2011 Mar 31.

    PMID: 21458181BACKGROUND
  • Huang Y, Liu Z, He L, Chen X, Pan D, Ma Z, Liang C, Tian J, Liang C. Radiomics Signature: A Potential Biomarker for the Prediction of Disease-Free Survival in Early-Stage (I or II) Non-Small Cell Lung Cancer. Radiology. 2016 Dec;281(3):947-957. doi: 10.1148/radiol.2016152234. Epub 2016 Jun 27.

    PMID: 27347764BACKGROUND
  • Inamura K. Lung Cancer: Understanding Its Molecular Pathology and the 2015 WHO Classification. Front Oncol. 2017 Aug 28;7:193. doi: 10.3389/fonc.2017.00193. eCollection 2017.

    PMID: 28894699BACKGROUND
  • Groheux D, Quere G, Blanc E, Lemarignier C, Vercellino L, de Margerie-Mellon C, Merlet P, Querellou S. FDG PET-CT for solitary pulmonary nodule and lung cancer: Literature review. Diagn Interv Imaging. 2016 Oct;97(10):1003-1017. doi: 10.1016/j.diii.2016.06.020. Epub 2016 Aug 24.

    PMID: 27567555BACKGROUND
  • Chao F, Zhang H. PET/CT in the staging of the non-small-cell lung cancer. J Biomed Biotechnol. 2012;2012:783739. doi: 10.1155/2012/783739. Epub 2012 Mar 7.

    PMID: 22577296BACKGROUND
  • Quint LE, Tummala S, Brisson LJ, Francis IR, Krupnick AS, Kazerooni EA, Iannettoni MD, Whyte RI, Orringer MB. Distribution of distant metastases from newly diagnosed non-small cell lung cancer. Ann Thorac Surg. 1996 Jul;62(1):246-50. doi: 10.1016/0003-4975(96)00220-2.

    PMID: 8678651BACKGROUND
  • Chang CF, Rashtian A, Gould MK. The use and misuse of positron emission tomography in lung cancer evaluation. Clin Chest Med. 2011 Dec;32(4):749-62. doi: 10.1016/j.ccm.2011.08.012.

    PMID: 22054883BACKGROUND
  • Ma W, Wang M, Li X, Huang H, Zhu Y, Song X, Dai D, Xu W. Quantitative 18F-FDG PET analysis in survival rate prediction of patients with non-small cell lung cancer. Oncol Lett. 2018 Oct;16(4):4129-4136. doi: 10.3892/ol.2018.9166. Epub 2018 Jul 18.

    PMID: 30214552BACKGROUND
  • Yoon DH, Baek S, Choi CM, Lee DH, Suh C, Ryu JS, Moon DH, Lee JS, Kim SW. FDG-PET as a potential tool for selecting patients with advanced non-small cell lung cancer who may be spared maintenance therapy after first-line chemotherapy. Clin Cancer Res. 2011 Aug 1;17(15):5093-100. doi: 10.1158/1078-0432.CCR-10-2791. Epub 2011 Jun 14.

    PMID: 21673067BACKGROUND
  • Takahashi R, Hirata H, Tachibana I, Shimosegawa E, Inoue A, Nagatomo I, Takeda Y, Kida H, Goya S, Kijima T, Yoshida M, Kumagai T, Kumanogoh A, Okumura M, Hatazawa J, Kawase I. Early [18F]fluorodeoxyglucose positron emission tomography at two days of gefitinib treatment predicts clinical outcome in patients with adenocarcinoma of the lung. Clin Cancer Res. 2012 Jan 1;18(1):220-8. doi: 10.1158/1078-0432.CCR-11-0868. Epub 2011 Oct 21.

    PMID: 22019513BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Taha Zaky Mahran, Prof.Dr.

    Assiut University

    STUDY CHAIR
  • Ahmad Zaher, Prof .Dr.

    National Cancer Institute (NCI)

    STUDY CHAIR
  • Nesreen Mekkawy, Dr.

    Assiut University

    STUDY CHAIR

Central Study Contacts

Walaa Otify Thabet, MD

CONTACT

Hemat E Mahmoud, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer-principal investigator

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 20, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

May 20, 2020

Record last verified: 2020-05