- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004138
Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
Florida
-
Clearwater, Florida, United States, 33756
- Morton Plant Mease Health Care
-
Lakeland, Florida, United States, 33805-4500
- Lakeland Regional Medical Center
-
-
Illinois
-
Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
-
Park Ridge, Illinois, United States, 60068
- Lutheran General Hospital
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
-
Iowa City, Iowa, United States, 52246-2208
- Veterans Affairs Medical Center - Iowa City
-
-
Maryland
-
Baltimore, Maryland, United States, 21201-1590
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States, 10029-6574
- Mount Sinai School of Medicine
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
-
-
Pennsylvania
-
Greensburg, Pennsylvania, United States, 15601-2282
- Westmoreland Hospital
-
New Castle, Pennsylvania, United States, 16105
- Jameson Memorial Hospital
-
Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Cancer Institute
-
Pittsburgh, Pennsylvania, United States, 15212-4772
- Allegheny General Hospital
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
-
-
Utah
-
Salt Lake City, Utah, United States, 84143
- Latter Day Saints Hospital
-
-
Virginia
-
Richmond, Virginia, United States, 23298-0037
- Massey Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient must be ≥ 18 years of age.
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.
- Patient must be medically fit for surgical staging procedures following the thoracic surgeon's evaluation of general medical fitness.
- Patient must be a candidate for resection of the clinical stage I, II, or IIIa lesion.
- Patient must be able to tolerate PET, (i.e., not claustrophobic and able to lie supine for 1.5 hrs).
- A signed and dated written informed consent must be obtained from the patient or the patient's legally acceptable representative prior to study participation.
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.
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
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:
- Patient has had a prior PET scan for evaluation of their NSCLC.
- 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.
- Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value >200 mg/dL, within 12 hours of PET scan.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FDG-PET scan + surgery
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with negative findings from FDG-PET scan
Time Frame: Up to 1 month post-FDG-PET scan
|
Up to 1 month post-FDG-PET scan
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of false-positive lesions found by FDG-PET
Time Frame: Up to 6 months post-surgery
|
Up to 6 months post-surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Carolyn E. Reed, MD, Medical University of South Carolina
Publications and helpful links
General Publications
- Kozower BD, Meyers BF, Reed CE, Jones DR, Decker PA, Putnam JB Jr. Does positron emission tomography prevent nontherapeutic pulmonary resections for clinical stage IA lung cancer? Ann Thorac Surg. 2008 Apr;85(4):1166-9; discussion 1169-70. doi: 10.1016/j.athoracsur.2008.01.018.
- Reed CE, Harpole DH, Posther KE, Woolson SL, Downey RJ, Meyers BF, Heelan RT, MacApinlac HA, Jung SH, Silvestri GA, Siegel BA, Rusch VW; American College of Surgeons Oncology Group Z0050 trial. Results of the American College of Surgeons Oncology Group Z0050 trial: the utility of positron emission tomography in staging potentially operable non-small cell lung cancer. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1943-51. doi: 10.1016/j.jtcvs.2003.07.030. Erratum In: J Thorac Cardiovasc Surg. 2007 Apr;133(4):864.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACOSOG-Z0050
- CDR0000067368 (REGISTRY: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on fludeoxyglucose F 18
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI)TerminatedCervical CancerUnited States
-
University of SaskatchewanSaskatoon Health Region; Sylvia Fedoruk Canadian Centre for Nuclear InnovationCompletedPositron-Emission Tomography and Cone-Beam Computed Tomography
-
University of UtahTerminatedMalignant NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma... and other conditionsUnited States
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI)TerminatedLung CancerUnited States
-
Chang Gung Memorial HospitalCompleted
-
University of WashingtonNational Cancer Institute (NCI)TerminatedRecurrent Breast Carcinoma | Estrogen Receptor Positive | Stage IV Breast Cancer AJCC v6 and v7United States
-
University Hospital, BrestCompletedUnspecified Adult Solid Tumor, Protocol Specific | ThromboembolismFrance
-
Children's Hospital of PhiladelphiaTerminatedNeurofibromatosis Type 1 | Precancerous ConditionUnited States
-
Chang Gung Memorial HospitalCompletedFrontotemporal Dementia | Progressive Supranuclear Palsy | Alzheimer's Disease | Vascular Cognitive Impairment | Cortical Basal SyndromeTaiwan