Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Jul 13, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Jonsson Comprehensive Cancer Center, UCLALos Angeles, California
- UCSF Cancer Center and Cancer Research InstituteSan Francisco, California
- Morton Plant Mease Health CareClearwater, Florida
- Lakeland Regional Medical CenterLakeland, Florida
- University of Chicago Cancer Research CenterChicago, Illinois
- Lutheran General HospitalPark Ridge, Illinois
- Indiana University Cancer CenterIndianapolis, Indiana
- Holden Comprehensive Cancer CenterIowa City, Iowa
- Veterans Affairs Medical Center - Iowa CityIowa City, Iowa
- Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- William Beaumont HospitalRoyal Oak, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2016. Always confirm current availability with the study team.