Positron Emission Tomography for Detecting Non-small Cell Lung Cancer

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00004138

Run by

Alliance for Clinical Trials in Oncology

People needed

303

Starts

1999-09-01

Expected to finish

2002-12-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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