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: September 29, 2014
Last verified: September 2014

August 9, 2008
September 29, 2014
January 2004
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Survival rate at 2 years [ Designated as safety issue: No ]
  • Recurrence rate at 2 years [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00732563 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Positive threshold of lymph node radioactivity [ 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 [ Designated as safety issue: No ]
  • Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Cost [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lung Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00732563
CDR0000601525, RPCI-I-97306
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Chukwumere E. Nwogu, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP