Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments chemotherapy, lymphadenectomy, neoadjuvant therapy, quality-of-life assessment, therapeutic conventional surgery, thoracic surgical procedure, fludeoxyglucose f 18, radiation therapy
Sponsor Roswell Park Cancer Institute
Start date January 2004
End date June 2014
Trial size 100 participants
Trial identifier NCT00732563, CDR0000601525, RPCI-I-97306

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
Survival rate at 2 years
time frame: 2 years
Recurrence rate at 2 years
time frame: 2 years

Secondary Outcomes

Measure
Positive threshold of lymph node radioactivity
time frame: within 90 days
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
Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging
time frame: Within 90 days
Quality of life
time frame: At 3 years

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer
Principal investigator Chukwumere E. Nwogu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Roswell Park Cancer Institute.