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

May 15, 2020 updated by: Walaa Otify Thabet, Assiut University
Describe strengths and limitations of FDG PET/CT for staging. Evaluate the utility of PET/CT in assessment of therapy response and restaging

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET/CT in lung cancer
Time Frame: one year
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET/CT in lung cancer
Time Frame: one year
-To evaluate risk benefit of PET/CT examination in lung cancer patients.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Taha Zaky Mahran, Prof.Dr., Assiut University
  • Study Chair: Ahmad Zaher, Prof .Dr., National Cancer Institute (NCI)
  • Study Chair: Nesreen Mekkawy, Dr., Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET/CT in lung cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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