Fludeoxyglucose F 18 in Detecting Lymph Node Metastasis in Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732563
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Diagnostic procedures using fludeoxyglucose F 18 and a surgical probe may help find lymph node metastases in patients with early-stage non-small cell lung cancer.

PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 works in detecting lymph node metastasis in patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: chemotherapy Procedure: lymphadenectomy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Procedure: thoracic surgical procedure Radiation: fludeoxyglucose F 18 Radiation: radiation therapy Not Applicable

Detailed Description:



  • Determine the positive threshold of lymph node radioactivity after fludeoxyglucose F 18, utilizing the gamma probe, in patients with resectable stage I or II non-small cell lung cancer.
  • Compare the accuracy of detecting thoracic lymph node metastases using positron emission tomography-computed tomography (PET-CT) versus the intra-operative hand-held gamma probe in these patients.
  • Determine the ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging in these patients.
  • Assess the clinical relevance of the gamma probe-detected lymph node metastases by measuring patient survival, tumor recurrence, impact on patient quality of life, and cost.

OUTLINE: Patients undergo a positron emission tomography-computed tomography (PET-CT) scan within 90 days before surgery. Beginning 1-4 hours before surgery on day 1, patients receive an injection of fludeoxyglucose F 18 (FDG) and a mediastinoscopy is performed. FDG-avid lymph nodes are obtained and may undergo immunohistochemical analysis or standard analysis. Patients with mediastinal lymph node micrometastasis do not undergo primary tumor resection. Patients with ipsilateral mediastinal micrometastases undergo neoadjuvant chemotherapy prior to surgical resection. Patients with contralateral mediastinal micrometastases undergo definitive chemoradiotherapy. In the absence of mediastinal lymph node metastases (micro or macro), complete surgical resection is performed after the mediastinoscopy, including complete thoracic lymphadenectomy. The tumor and lymph nodes (both from mediastinoscopy and thoracotomy) undergo radioactivity measurements with the hand-held gamma probe. Fresh tumor and lymph node samples are stored for future studies.

Patients complete the Short Form 36 Health Survey (SF-36) before surgery and at 1, 3, and 6 months after surgery to assess the potential impact of the gamma probe on patient quality of life.

After completion of study, patients are followed every 6 months for 2 years, and then annually for 3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer
Actual Study Start Date : July 16, 2008
Actual Primary Completion Date : June 29, 2012
Actual Study Completion Date : July 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Drug: chemotherapy
    Given IV and Orally
  • Procedure: lymphadenectomy
    Removal of lymph nodes
  • Procedure: neoadjuvant therapy
    Tumor reduction
  • Procedure: quality-of-life assessment
    Correlative Study
  • Procedure: therapeutic conventional surgery
    Treatment for cancer
  • Procedure: thoracic surgical procedure
    removal of tissue
  • Radiation: fludeoxyglucose F 18
    given IV
  • Radiation: radiation therapy
    undergoing radiotherapy

Primary Outcome Measures :
  1. Survival rate at 2 years [ Time Frame: 2 years ]
  2. Recurrence rate at 2 years [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Positive threshold of lymph node radioactivity [ Time Frame: within 90 days ]
  2. Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe [ Time Frame: Within 90 days ]
  3. Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging [ Time Frame: Within 90 days ]
  4. Quality of life [ Time Frame: At 3 years ]

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of non-small cell lung cancer

    • Stage I-II disease
    • Resectable disease
  • Planning to undergo surgical resection
  • No tumors that are not fludeoxyglucose F 18 (FDG)-avid on PET scan


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No previous allergic reaction to fludeoxyglucose F 18
  • No contraindication to a pulmonary lobectomy and lymphadenectomy


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732563

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Chukwumere E. Nwogu, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00732563     History of Changes
Other Study ID Numbers: CDR0000601525
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roswell Park Cancer Institute:
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action