search
Back to results

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

Primary Purpose

Non-small Cell Lung Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
Sponsored by
Latin American Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Carcinoma focused on measuring Non-small cell lung carcinoma, PET/CT, 18F-FDG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • Pregnant women
  • Patients with other types of patients

Sites / Locations

  • Instituto do Cérebro do Rio Grande do Sul

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnosis or suspicion of non-small cell lung carcinoma

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients diagnosed in a positive manner with the gold standard and with the alternative method
Number of patients with a negative diagnosis according to the gold standard and the alternative method
Number of true positives among positive diagnosed patients with the alternative method
Number of false positives among patients negatively diagnosed with the alternative method

Full Information

First Posted
January 22, 2016
Last Updated
February 22, 2017
Sponsor
Latin American Cooperative Oncology Group
Collaborators
Instituto do Cérebro do Rio Grande do Sul - InsCer, Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT02664792
Brief Title
Use of [18]F-FDG on PET/CT as an Alternative Non-invasive Method for Staging of Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Latin American Cooperative Oncology Group
Collaborators
Instituto do Cérebro do Rio Grande do Sul - InsCer, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Carcinoma
Keywords
Non-small cell lung carcinoma, PET/CT, 18F-FDG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnosis or suspicion of non-small cell lung carcinoma
Arm Type
Experimental
Arm Description
SUS patients with diagnosis or suspicion of non-small cell lung carcinoma with an indication for mediastinoscopy
Intervention Type
Other
Intervention Name(s)
Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
Primary Outcome Measure Information:
Title
Validate the [18F]FDG as an alternative method for non-small lung carcinoma diagnosis
Time Frame
4 years
Secondary Outcome Measure Information:
Title
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
Title
Number of patients with a negative diagnosis according to the gold standard and the alternative method
Time Frame
up to 30 days following recruitment
Title
Number of true positives among positive diagnosed patients with the alternative method
Time Frame
up to 30 days following recruitment
Title
Number of false positives among patients negatively diagnosed with the alternative method
Time Frame
up to 30 days following recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Women of childbearing potential using contraceptive methods and negative pregnancy test Adults with more than 18 years old. Both genders Exclusion Criteria: Pregnant women Patients with other types of patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Werutsky, MD
Organizational Affiliation
Latin American Cooperative Oncology Group
Official's Role
Study Director
Facility Information:
Facility Name
Instituto do Cérebro do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17873159
Citation
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.
Results Reference
background
PubMed Identifier
12527563
Citation
Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.
Results Reference
background
PubMed Identifier
18452692
Citation
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.
Results Reference
background
PubMed Identifier
23649444
Citation
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.
Results Reference
background
PubMed Identifier
23657161
Citation
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.
Results Reference
background
PubMed Identifier
22772365
Citation
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.
Results Reference
background
PubMed Identifier
18988199
Citation
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.
Results Reference
background
PubMed Identifier
19149611
Citation
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.
Results Reference
background
PubMed Identifier
11839070
Citation
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.
Results Reference
background
PubMed Identifier
28524975
Citation
Zanzonico P. Basic Sciences of Nuclear Medicine. Med Phys. 2011 Sep;38(9):5265-5266. doi: 10.1118/1.3626488. No abstract available.
Results Reference
background
Citation
March 10, 2000 Federal Register, Docket No 00N-0553, p.p. 12999-13010
Results Reference
background
Citation
VALLABHAJOSULA, S. Molecular Imaging: radiopharmaceuticals for PET and SPECT. New York: Springer, 2009. 371p.
Results Reference
background
PubMed Identifier
23842577
Citation
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.
Results Reference
background
PubMed Identifier
14644890
Citation
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.
Results Reference
background
PubMed Identifier
19464906
Citation
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.
Results Reference
background
Citation
Product Information: Fludeoxyglucose F18 IV injection, Fludeoxyglucose F18 IV injection. Feinstein Institute for Medical Research, Manhasset, NY, 2010.
Results Reference
background
PubMed Identifier
12954688
Citation
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.
Results Reference
background
PubMed Identifier
9460106
Citation
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.
Results Reference
background
PubMed Identifier
18483141
Citation
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.
Results Reference
background
PubMed Identifier
30606144
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs