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
NCT ID: NCT00732563
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-07-16
2017-07-26
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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chemotherapy
Given IV and Orally
lymphadenectomy
Removal of lymph nodes
neoadjuvant therapy
Tumor reduction
quality-of-life assessment
Correlative Study
therapeutic conventional surgery
Treatment for cancer
thoracic surgical procedure
removal of tissue
fludeoxyglucose F 18
given IV
radiation therapy
undergoing radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Chukwumere E. Nwogu, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-I-97306
Identifier Type: -
Identifier Source: secondary_id
CDR0000601525
Identifier Type: -
Identifier Source: org_study_id