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CompletedNCT02664792Updated Feb 23, 2017

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

An interventional study of Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma in Non-small Cell Lung Carcinoma, sponsored by Latin American Cooperative Oncology Group. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Latin American Cooperative Oncology Group · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Aug 2014, registered Jan 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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
02

Conditions studied

  • Non-small Cell Lung Carcinoma

Keywords

  • Non-small cell lung carcinoma
  • PET/CT
  • 18F-FDG
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 108 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Latin American Cooperative Oncology Group is the lead sponsor of 46 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Patients with other types of patients
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Diagnosis or suspicion of non-small cell lung carcinoma

    SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy

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

Interventions

  • OtherUse of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
06

What researchers measure

Primary outcomes

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

    Time frame: 4 years

Secondary outcomes

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

    Time frame: up to 30 days following recruitment

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

    Time frame: up to 30 days following recruitment

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

    Time frame: up to 30 days following recruitment

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

    Time frame: up to 30 days following recruitment

07

Study locations

1 site
  • Instituto do Cérebro do Rio Grande do Sul
    Porto Alegre, Rio Grande do Sul, Brazil
08

References and documents

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 ↗
  • Product Information: Fludeoxyglucose F18 IV injection, Fludeoxyglucose F18 IV injection. Feinstein Institute for Medical Research, Manhasset, NY, 2010.
  • Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453. Erratum In: Emerg Med J. 2004 Jan;21(1):126. Emerg Med J. 2023 Oct;40(10):e4. doi: 10.1136/emj.20.5.453corr2. PubMed 12954688 ↗
  • Erasmus JJ, McAdams HP, Patz EF Jr, Goodman PC, Coleman RE. Thoracic FDG PET: state of the art. Radiographics. 1998 Jan-Feb;18(1):5-20. doi: 10.1148/radiographics.18.1.9460106. PubMed 9460106 ↗
  • Singh J, Daftary A. Iodinated contrast media and their adverse reactions. J Nucl Med Technol. 2008 Jun;36(2):69-74; quiz 76-7. doi: 10.2967/jnmt.107.047621. Epub 2008 May 15. PubMed 18483141 ↗
  • Werutsky G, Hochhegger B, Lopes de Figueiredo Pinto JA, Martinez-Mesa J, Zanini ML, Berdichevski EH, Vilas E, da Silva VD, Tsukazan MTR, Vieira A, Fritscher LG, Hartmann L, Alba M, Sartori G, Matushita C, Bortolotto V, do Amaral RR, Junior LCA, Zaffaroni F, Barrios CH, Debiasi M, Frietscher CC. PET-CT has low specificity for mediastinal staging of non-small-cell lung cancer in an endemic area for tuberculosis: a diagnostic test study (LACOG 0114). BMC Cancer. 2019 Jan 3;19(1):5. doi: 10.1186/s12885-018-5233-5. PubMed 30606144 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02664792
Lead sponsor
Latin American Cooperative Oncology Group
Collaborators
Instituto do Cérebro do Rio Grande do Sul - InsCer, Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Sponsor
First posted
Jan 27, 2016
Start date
Aug 2014
Primary completion
Jul 2016
Completion
Dec 2016
Last update
Feb 23, 2017

Study contacts

Gustavo Werutsky, MD
study director · Latin American Cooperative Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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