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Completed

NCT Number: NCT00732563

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

Given IV and Orally

Lymphadenectomy

Procedure

Removal of lymph nodes

neoadjuvant therapy

Procedure

Tumor reduction

quality-of-life assessment

Procedure

Correlative Study

therapeutic conventional surgery

Procedure

Treatment for cancer

thoracic surgical procedure

Procedure

removal of tissue

fludeoxyglucose F 18

Radiation

given IV

radiation therapy

Radiation

undergoing radiotherapy

Primary outcomes

  1. Survival rate at 2 years

    Time frame: 2 years

  2. Recurrence rate at 2 years

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer

Important dates

Study start
2008
Primary completion
2012
Study completion
2017
First posted
Aug 12, 2008
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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