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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00732563
First received: August 9, 2008
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Survival rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Recurrence rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive threshold of lymph node radioactivity [ Time Frame: within 90 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At 3 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2004
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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
Detailed Description:

OBJECTIVES:

Primary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732563

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

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00732563     History of Changes
Other Study ID Numbers: CDR0000601525, RPCI-I-97306
Study First Received: August 9, 2008
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014