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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000067368 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDG-PET scan + surgery | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography | Procedure |
| ||
| radionuclide imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with negative findings from FDG-PET scan | Up to 1 month post-FDG-PET scan |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of false-positive lesions found by FDG-PET | Up to 6 months post-surgery |
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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;
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.
Patient must complete the following standard staging procedures 60 days prior to registration.
A cancer survivor is eligible provided that ALL the following criteria are met and documented:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn E. Reed, MD | Medical University of South Carolina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States | ||
| UCSF Cancer Center and Cancer Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18355490 | Result | 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. | |
| 14688710 | Result | 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. |
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| Procedure |
|
| fludeoxyglucose F 18 | Radiation |
|
| San Francisco |
| California |
| 94143-0128 |
| United States |
| Morton Plant Mease Health Care | Clearwater | Florida | 33756 | United States |
| Lakeland Regional Medical Center | Lakeland | Florida | 33805-4500 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242-1009 | United States |
| Veterans Affairs Medical Center - Iowa City | Iowa City | Iowa | 52246-2208 | United States |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201-1590 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029-6574 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Westmoreland Hospital | Greensburg | Pennsylvania | 15601-2282 | United States |
| Jameson Memorial Hospital | New Castle | Pennsylvania | 16105 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4772 | United States |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| Latter Day Saints Hospital | Salt Lake City | Utah | 84143 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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