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AzTrials

Lung CancerNCT04395651

The Role of 18F-FDG-PET/CT Scan in Lung Cancer Patients

An observational study of Lung Cancer, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Lung Cancer
What is being tested?
PET/CT
Type of treatment
Medical device
How many people
30 participants
Where
No sites listed yet
Study dates
May 2020to Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Walaa Otify Thabet, MD contact

01020140716

dr.walaaotify@yahoo.com

Hemat E Mahmoud, Dr. contact

01005052031

Tahamohran@hotmail.com

About this study

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

Read the detailed description

Lung cancer is one of the most common cancers and it represents the main cause of cancer mortality worldwide.

It is histopathological classified into main groups: Small cell lung cancer (15%) and Non-small cell lung cancer (85%). NSCLCs are generally subcategorized into adenocarcinoma, squamous cell carcinoma (SqCC), and large cell carcinoma. Positron emission tomography (PET) is now an important cancer imaging tool, both for diagnosis and staging, as well as offering prognostic information based on response.

PET sets the gold standard in the evaluation of an indeterminate solitary pulmonary nodule or mass, where PET has proven to be significantly more accurate than computed tomography (CT).

For NSCLC chest CT is the standard imaging modality for assessing primary tumor size and identifying its margins. PET-CT may be helpful in assessing a nodule located in same lobe. It can also provide information on parietal or mediastinal involvement. PET is useful for differentiating tumor tissue from atelectasis, which may be helpful if radiotherapy is planned to determine the target volume .

In the evaluation of metastatic spread to loco-regional lymph nodes, PET is significantly more accurate than CT, so that invasive surgical staging may be omitted in many patients with negative mediastinal PET images.

In patients with positive mediastinal PET images, invasive surgical staging remains mandatory because of the possibility of false-positive findings due to inflammatory nodes or granulomatous disorders.

Forty percent of patients with NSCLC have distant metastases at presentation, most commonly in the adrenal glands, bones, liver, or brain .

In the search for metastatic spread, PET is a useful adjunct to conventional imaging. This may be due to the finding of unexpected metastatic lesions or due to exclusion of malignancy in lesions that are equivocal on standard imaging. However, at this time, PET does not replace conventional imaging.

The diagnostic accuracy of initial pre-therapy PET-CT results in improved staging, and thus is of high prognostic value.

Many studies conducted the value of using semi-quantitative measures as metabolic tumor volume (MTV) and Total lesion glycolysis (TLG) in predicting prognosis and survival rather than the traditional method of measuring Standard uptake value (SUV).

Several studies have demonstrated that PET imaging proves useful for assessing the response to chemo therapy or targeted therapy in patients with metastatic NSCLC.

Conditions
Lung Cancer
Being tested
PET/CT
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: one year

Secondary outcomes (1)

  1. PET/CT in lung cancer

    -To evaluate risk benefit of PET/CT examination in lung cancer patients.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study startMay 2020 (estimated)
  3. Primary completionMay 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395651
Sponsor's protocol ID
PET/CT in lung cancer
Status last verified
May 2020
First submitted
13 May 2020
Last updated
20 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21458181

  • 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.

    PubMed 27347764

  • 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.

    PubMed 28894699

  • 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.

    PubMed 27567555

  • 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.

    PubMed 22577296

  • 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.

    PubMed 8678651

  • 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.

    PubMed 22054883

  • 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.

    PubMed 30214552

  • 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.

    PubMed 21673067

  • 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.

    PubMed 22019513

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Walaa Otify Thabet, MD (01020140716, dr.walaaotify@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PET/CT in lung cancer (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04395651, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.

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