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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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chemotherapy
lymphadenectomy
neoadjuvant therapy
quality-of-life assessment
therapeutic conventional surgery
thoracic surgical procedure
fludeoxyglucose F 18
radiation therapy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Survival rate at 2 years
Recurrence rate at 2 years

Secondary Outcome Measures

Positive threshold of lymph node radioactivity
Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe
Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging
Quality of life

Full Information

First Posted
August 9, 2008
Last Updated
October 16, 2017
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00732563
Brief Title
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
Official Title
Radioguided Detection of Lymph Node Metastasis in Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 16, 2008 (Actual)
Primary Completion Date
June 29, 2012 (Actual)
Study Completion Date
July 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Description
Given IV and Orally
Intervention Type
Procedure
Intervention Name(s)
lymphadenectomy
Intervention Description
Removal of lymph nodes
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Description
Tumor reduction
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Correlative Study
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Treatment for cancer
Intervention Type
Procedure
Intervention Name(s)
thoracic surgical procedure
Intervention Description
removal of tissue
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Description
given IV
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
undergoing radiotherapy
Primary Outcome Measure Information:
Title
Survival rate at 2 years
Time Frame
2 years
Title
Recurrence rate at 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Positive threshold of lymph node radioactivity
Time Frame
within 90 days
Title
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
Title
Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging
Time Frame
Within 90 days
Title
Quality of life
Time Frame
At 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chukwumere E. Nwogu, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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