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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732563
• Other study ID #: CDR0000601525
• Secondary ID: RPCI-I-97306
• Status: Completed
• Phase: N/A
• First received: August 9, 2008
• Last updated: October 16, 2017
• Start date: July 16, 2008
• Est. completion date: July 26, 2017

Study information

• Verified date: October 2017
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 26, 2017
• Est. primary completion date: June 29, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• chemotherapy
Given IV and Orally

Procedure:
• 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

Radiation:
• fludeoxyglucose F 18
given IV
• radiation therapy
undergoing radiotherapy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate at 2 years		2 years
Primary	Recurrence rate at 2 years		2 years
Secondary	Positive threshold of lymph node radioactivity		within 90 days
Secondary	Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe		Within 90 days
Secondary	Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging		Within 90 days
Secondary	Quality of life		At 3 years