Positron Emission Tomography for Detecting Non-small Cell Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18

• Registration Number: NCT00004138
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Imaging procedures, such as positron emission tomography (PET), may improve the ability to detect the extent of non-small cell lung cancer.

PURPOSE: Diagnostic trial to study the effectiveness of PET for detecting lesions in patients who have newly diagnosed stage I, stage II, or stage IIIA non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary Objective: To ascertain whether FDG-PET scanning can detect lesions that would preclude pulmonary resection in patients found to be surgical candidates by standard imaging procedures.

Secondary Objectives: To use the data collected to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET is best able to identify.

Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy, fine needle aspiration, or other imaging studies are then conducted to confirm the PET findings.

Patients with no mediastinal nodal or distant metastases identified by FDG-PET scan may undergo thoracotomy and pulmonary resection within 1 month of evaluation.

Patients are followed at 5-6 months after surgery.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 1999-12-10
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

1. Patient must be ≥ 18 years of age.

2. a) Patient must have histologically or cytologically confirmed, newly diagnosed, untreated, single lesion bronchogenic NSCLC (adenocarcinoma, non-lobar/non- diffuse bronchioloalveolor cell carcinoma, large cell carcinoma, or squamous cell carcinoma). OR b) Patient is eligible based upon mediastinal node histology diagnosed by transbronchial biopsy, and if a separate ipsilateral lung lesion is clearly evident on radiographs, biopsy of the lung tumor is not required for this patient. OR c) Patient may be eligible without histologic or cytologic proof if;

   • The patient is strongly suspected to have primary bronchogenic carcinoma (e.g., heavy smoker with a new peripheral mass with typical appearance of lung cancer on chest radiograph although bronchoscopy and/or fine needle aspiration is nondiagnostic), and
   • The tumor is clinically resectable, and
   • An exploratory thoracotomy is planned.

3. Patient must be medically fit for surgical staging procedures following the thoracic surgeon's evaluation of general medical fitness.

4. Patient must be a candidate for resection of the clinical stage I, II, or IIIa lesion.

5. Patient must be able to tolerate PET, (i.e., not claustrophobic and able to lie supine for 1.5 hrs).

6. A signed and dated written informed consent must be obtained from the patient or the patient's legally acceptable representative prior to study participation.

7. Female patient of childbearing potential must have a negative serum or urine pregnancy test, 72 hours prior to FDG-PET.

   • NOTE: This is in order to avoid unnecessary fetal radiation exposure and because the use of furosemide is contraindicated in pregnancy.

8. Patient must complete the following standard staging procedures 60 days prior to registration.

   • CT scan of the chest and upper abdomen (include adrenals) with contrast
   • NOTE: Non-contrast CT scan may be used for patients with a peripheral suspicious nodule and no evidence of hilar or mediastinal adenopathy or invasion of central structures. All other lesions require IV contrast.
   • Bone scan
   • CT scan of the brain with and without contrast or MRI of brain

9. A cancer survivor is eligible provided that ALL the following criteria are met and documented:

   • the patient has undergone potentially curative therapy for all prior malignancies, and
   • there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer), and
   • the patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria

1. Patient has had a prior PET scan for evaluation of their NSCLC.
2. Patient has evidence of stage IIIB or IV disease confirmed by diagnostic imaging such as chest X-ray, CT chest, CT abdomen, CT brain or MRI brain, and bone scan.
3. Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value >200 mg/dL, within 12 hours of PET scan.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG-PET scan + surgery	radionuclide imaging	Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy, fine needle aspiration, or other imaging studies are then conducted to confirm the PET findings. Patients with no mediastinal nodal or distant metastases identified by FDG-PET scan may undergo thoracotomy and pulmonary resection within 1 month of evaluation. Patients are followed at 5-6 months after surgery.
FDG-PET scan + surgery	positron emission tomography	Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy, fine needle aspiration, or other imaging studies are then conducted to confirm the PET findings. Patients with no mediastinal nodal or distant metastases identified by FDG-PET scan may undergo thoracotomy and pulmonary resection within 1 month of evaluation. Patients are followed at 5-6 months after surgery.
FDG-PET scan + surgery	fludeoxyglucose F 18	Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy, fine needle aspiration, or other imaging studies are then conducted to confirm the PET findings. Patients with no mediastinal nodal or distant metastases identified by FDG-PET scan may undergo thoracotomy and pulmonary resection within 1 month of evaluation. Patients are followed at 5-6 months after surgery.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with negative findings from FDG-PET scan	Up to 1 month post-FDG-PET scan

Secondary Outcome Measures

Name	Time	Method
Proportion of false-positive lesions found by FDG-PET	Up to 6 months post-surgery

Trial Locations

Locations (23)

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Morton Plant Mease Health Care; 🇺🇸 Clearwater, Florida, United States

Lakeland Regional Medical Center; 🇺🇸 Lakeland, Florida, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Veterans Affairs Medical Center - Iowa City; 🇺🇸 Iowa City, Iowa, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Westmoreland Hospital; 🇺🇸 Greensburg, Pennsylvania, United States

Jameson Memorial Hospital; 🇺🇸 New Castle, Pennsylvania, United States

Western Pennsylvania Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Holden Comprehensive Cancer Center; 🇺🇸 Iowa City, Iowa, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Latter Day Saints Hospital; 🇺🇸 Salt Lake City, Utah, United States

Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States