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

NCT00732563 | Completed DMC

• 2 other identifiers: CDR0000601525RPCI-I-97306
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Survival rate at 2 years

  2 years

• Recurrence rate at 2 years

  2 years

Secondary Outcomes (4)

• Positive threshold of lymph node radioactivity

  within 90 days

• Comparison of the accuracy of detecting thoracic lymph node metastases using PET-CT scans versus intra-operative hand-held gamma probe

  Within 90 days

• Ability of the gamma probe to detect lymph node micrometastases, resulting in upstaging

  Within 90 days

• Quality of life

  At 3 years

Interventions

chemotherapy DRUG

Given IV and Orally

lymphadenectomy PROCEDURE

Removal of lymph nodes

neoadjuvant therapy PROCEDURE

Tumor reduction

quality-of-life assessment PROCEDURE

Correlative Study

therapeutic conventional surgery PROCEDURE

Treatment for cancer

thoracic surgical procedure PROCEDURE

removal of tissue

fludeoxyglucose F 18 RADIATION

given IV

radiation therapy RADIATION

undergoing radiotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Lymph Node Excision; Neoadjuvant Therapy; Thoracic Surgical Procedures; Fluorodeoxyglucose F18; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative; Combined Modality Therapy; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Chukwumere E. Nwogu, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2008
• First Posted: August 12, 2008
• Study Start: July 16, 2008
• Primary Completion: June 29, 2012
• Study Completion: July 26, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)