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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Survival rate at 2 years

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Chukwumere E. Nwogu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000601525

NCT ID:

NCT00732563

Start Date:

January 2004

Completion Date:

September 2013

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263