Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
NCT ID: NCT00004138
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
303 participants
INTERVENTIONAL
1999-09-30
2002-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Interventions
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positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Carolyn E. Reed, MD
Role: STUDY_CHAIR
Medical University of South Carolina
Locations
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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Morton Plant Mease Health Care
Clearwater, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, 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
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Iowa City
Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Westmoreland Hospital
Greensburg, Pennsylvania, United States
Jameson Memorial Hospital
New Castle, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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CDR0000067368
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0050
Identifier Type: -
Identifier Source: org_study_id
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