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Non-small Cell Lung CarcinomaNCT02664792

Use of [18]F-FDG on PET/CT as an Alternative Non-invasive Method for Staging of Lung Cancer

A study testing Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma in people with Non-small Cell Lung Carcinoma, run by Latin American Cooperative Oncology Group at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for staging of non-small cel lung carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Carcinoma
What is being tested?
Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteBrazil
Study dates
Aug 2014to Dec 2016
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma
  • Patients who previously underwent staging of the disease with CT
  • Clinical stages I-III AJCC 7th edition.
  • Patients with indication for mediastinoscopy and linfonodal biopsy
  • Patients without treatment for lung cancer
  • Patients with biochemical and haematological exams
Show all 9Show fewer
  • Women of childbearing potential using contraceptive methods and negative pregnancy test
  • Adults with more than 18 years old.
  • Both genders

Who cannot join

  • Pregnant women
  • Patients with other types of patients

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Cérebro do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Official title: Use of [18]F-FDG - PET/CT in Brazil Unified Health System (SUS) as an Alternative Non-invasive Method for Staging of Lung Cancer

To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for staging of non-small cel lung carcinoma.

Read the detailed description

The main aim of this study is to validate the [18F]FDG on PET/CT for the diagnosis of metastatic ganglions at the mediastinum in SUS patients with non-small cell lung carcinoma considering sensitivity, specificity, positive predictive value, negative predictive value, accuracy. Other specific aims are:

  • Analyze the diagnosis performance of the [18F]FDG on PET/CT in two timepoints (1 and 2 hours after exam), in relation to the staging of the non-small cell lung carcinoma
  • Evaluate the addition of the iodinated contrast in the [18F]FDG to improve the images obtained from the PET/CT in the staging of the non-small cell lung carcinoma
Being tested
Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
Keywords
Non-small cell lung carcinoma, PET/CT, 18F-FDG
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinomaOther

Study groups in NCT02664792
Study groupRoleWhat they receive
Diagnosis or suspicion of non-small cell lung carcinomaExperimentalSUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy
Receives: Other: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma

What is being measured

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

  1. Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis

    Measured: 4 years

Secondary outcomes (4)

  1. Number of patients diagnosed in a positive manner with the gold standard and with the alternative method

    Measured: up to 30 days following recruitment

  2. Number of patients with a negative diagnosis according to the gold standard and the alternative method

    Measured: up to 30 days following recruitment

  3. Number of true positives among positive diagnosed patients with the alternative method

    Measured: up to 30 days following recruitment

  4. Number of false positives among patients negatively diagnosed with the alternative method

    Measured: up to 30 days following recruitment

Timeline

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

  1. First posted27 Jan 2016 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2016
  4. Study completionDec 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664792
Sponsor's protocol ID
LACOG 0114
Status last verified
Feb 2017
First submitted
22 Jan 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Alberg AJ, Ford JG, Samet JM; American College of Chest Physicians. Epidemiology of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):29S-55S. doi: 10.1378/chest.07-1347.

    PubMed 17873159

  • Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.

    PubMed 12527563

  • Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008 May;83(5):584-94. doi: 10.4065/83.5.584.

    PubMed 18452692

  • Nana-Sinkam SP, Powell CA. Molecular biology of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e30S-e39S. doi: 10.1378/chest.12-2346.

    PubMed 23649444

  • Daigo Y, Takano A, Teramoto K, Chung S, Nakamura Y. A systematic approach to the development of novel therapeutics for lung cancer using genomic analyses. Clin Pharmacol Ther. 2013 Aug;94(2):218-23. doi: 10.1038/clpt.2013.90. Epub 2013 May 8.

    PubMed 23657161

  • Sommer G, Wiese M, Winter L, Lenz C, Klarhofer M, Forrer F, Lardinois D, Bremerich J. Preoperative staging of non-small-cell lung cancer: comparison of whole-body diffusion-weighted magnetic resonance imaging and 18F-fluorodeoxyglucose-positron emission tomography/computed tomography. Eur Radiol. 2012 Dec;22(12):2859-67. doi: 10.1007/s00330-012-2542-y. Epub 2012 Jul 9.

    PubMed 22772365

  • Miller PW, Long NJ, Vilar R, Gee AD. Synthesis of 11C, 18F, 15O, and 13N radiolabels for positron emission tomography. Angew Chem Int Ed Engl. 2008;47(47):8998-9033. doi: 10.1002/anie.200800222.

    PubMed 18988199

  • Leitha T. Nuclear medicine: proof of principle for targeted drugs in diagnosis and therapy. Curr Pharm Des. 2009;15(2):173-87. doi: 10.2174/138161209787002898.

    PubMed 19149611

  • Fowler JS, Ido T. Initial and subsequent approach for the synthesis of 18FDG. Semin Nucl Med. 2002 Jan;32(1):6-12. doi: 10.1053/snuc.2002.29270.

    PubMed 11839070

  • Zanzonico P. Basic Sciences of Nuclear Medicine. Med Phys. 2011 Sep;38(9):5265-5266. doi: 10.1118/1.3626488. No abstract available.

    PubMed 28524975

  • March 10, 2000 Federal Register, Docket No 00N-0553, p.p. 12999-13010

  • VALLABHAJOSULA, S. Molecular Imaging: radiopharmaceuticals for PET and SPECT. New York: Springer, 2009. 371p.

  • Murray CJ, Atkinson C, Bhalla K, Birbeck G, Burstein R, Chou D, Dellavalle R, Danaei G, Ezzati M, Fahimi A, Flaxman D, Foreman, Gabriel S, Gakidou E, Kassebaum N, Khatibzadeh S, Lim S, Lipshultz SE, London S, Lopez, MacIntyre MF, Mokdad AH, Moran A, Moran AE, Mozaffarian D, Murphy T, Naghavi M, Pope C, Roberts T, Salomon J, Schwebel DC, Shahraz S, Sleet DA, Murray, Abraham J, Ali MK, Atkinson C, Bartels DH, Bhalla K, Birbeck G, Burstein R, Chen H, Criqui MH, Dahodwala, Jarlais, Ding EL, Dorsey ER, Ebel BE, Ezzati M, Fahami, Flaxman S, Flaxman AD, Gonzalez-Medina D, Grant B, Hagan H, Hoffman H, Kassebaum N, Khatibzadeh S, Leasher JL, Lin J, Lipshultz SE, Lozano R, Lu Y, Mallinger L, McDermott MM, Micha R, Miller TR, Mokdad AA, Mokdad AH, Mozaffarian D, Naghavi M, Narayan KM, Omer SB, Pelizzari PM, Phillips D, Ranganathan D, Rivara FP, Roberts T, Sampson U, Sanman E, Sapkota A, Schwebel DC, Sharaz S, Shivakoti R, Singh GM, Singh D, Tavakkoli M, Towbin JA, Wilkinson JD, Zabetian A, Murray, Abraham J, Ali MK, Alvardo M, Atkinson C, Baddour LM, Benjamin EJ, Bhalla K, Birbeck G, Bolliger I, Burstein R, Carnahan E, Chou D, Chugh SS, Cohen A, Colson KE, Cooper LT, Couser W, Criqui MH, Dabhadkar KC, Dellavalle RP, Jarlais, Dicker D, Dorsey ER, Duber H, Ebel BE, Engell RE, Ezzati M, Felson DT, Finucane MM, Flaxman S, Flaxman AD, Fleming T, Foreman, Forouzanfar MH, Freedman G, Freeman MK, Gakidou E, Gillum RF, Gonzalez-Medina D, Gosselin R, Gutierrez HR, Hagan H, Havmoeller R, Hoffman H, Jacobsen KH, James SL, Jasrasaria R, Jayarman S, Johns N, Kassebaum N, Khatibzadeh S, Lan Q, Leasher JL, Lim S, Lipshultz SE, London S, Lopez, Lozano R, Lu Y, Mallinger L, Meltzer M, Mensah GA, Michaud C, Miller TR, Mock C, Moffitt TE, Mokdad AA, Mokdad AH, Moran A, Naghavi M, Narayan KM, Nelson RG, Olives C, Omer SB, Ortblad K, Ostro B, Pelizzari PM, Phillips D, Raju M, Razavi H, Ritz B, Roberts T, Sacco RL, Salomon J, Sampson U, Schwebel DC, Shahraz S, Shibuya K, Silberberg D, Singh JA, Steenland K, Taylor JA, Thurston GD, Vavilala MS, Vos T, Wagner GR, Weinstock MA, Weisskopf MG, Wulf S, Murray; U.S. Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013 Aug 14;310(6):591-608. doi: 10.1001/jama.2013.13805.

    PubMed 23842577

  • Gould MK, Kuschner WG, Rydzak CE, Maclean CC, Demas AN, Shigemitsu H, Chan JK, Owens DK. Test performance of positron emission tomography and computed tomography for mediastinal staging in patients with non-small-cell lung cancer: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):879-92. doi: 10.7326/0003-4819-139-11-200311180-00013.

    PubMed 14644890

  • Bille A, Pelosi E, Skanjeti A, Arena V, Errico L, Borasio P, Mancini M, Ardissone F. Preoperative intrathoracic lymph node staging in patients with non-small-cell lung cancer: accuracy of integrated positron emission tomography and computed tomography. Eur J Cardiothorac Surg. 2009 Sep;36(3):440-5. doi: 10.1016/j.ejcts.2009.04.003. Epub 2009 May 22.

    PubMed 19464906

Questions about this trial

What is this clinical trial studying?

A study testing Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma in people with Non-small Cell Lung Carcinoma, run by Latin American Cooperative Oncology Group at 1 site in Brazil.

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 9 inclusion and 2 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: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis (time frame: 4 years). 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 NCT02664792, which also lists 20 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 23 Feb 2017.

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