search
Back to results

Positron Emission Tomography for Detecting Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • UCSF Cancer Center and Cancer Research Institute
  • Morton Plant Mease Health Care
  • Lakeland Regional Medical Center
  • University of Chicago Cancer Research Center
  • Lutheran General Hospital
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Iowa City
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Massachusetts General Hospital Cancer Center
  • William Beaumont Hospital
  • Barnes-Jewish Hospital
  • Memorial Sloan-Kettering Cancer Center
  • Mount Sinai School of Medicine
  • Duke Comprehensive Cancer Center
  • Westmoreland Hospital
  • Jameson Memorial Hospital
  • Allegheny General Hospital
  • Western Pennsylvania Cancer Institute
  • Medical University of South Carolina
  • Latter Day Saints Hospital
  • Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDG-PET scan + surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of patients with negative findings from FDG-PET scan

Secondary Outcome Measures

Proportion of false-positive lesions found by FDG-PET

Full Information

First Posted
December 10, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004138
Brief Title
Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
Official Title
The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDG-PET scan + surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Procedure
Intervention Name(s)
radionuclide imaging
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Primary Outcome Measure Information:
Title
Proportion of patients with negative findings from FDG-PET scan
Time Frame
Up to 1 month post-FDG-PET scan
Secondary Outcome Measure Information:
Title
Proportion of false-positive lesions found by FDG-PET
Time Frame
Up to 6 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn E. Reed, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Morton Plant Mease Health Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805-4500
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Veterans Affairs Medical Center - Iowa City
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1590
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Westmoreland Hospital
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601-2282
Country
United States
Facility Name
Jameson Memorial Hospital
City
New Castle
State/Province
Pennsylvania
ZIP/Postal Code
16105
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Western Pennsylvania Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
Latter Day Saints Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18355490
Citation
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.
Results Reference
result
PubMed Identifier
14688710
Citation
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.
Results Reference
result

Learn more about this trial

Positron Emission Tomography for Detecting Non-small Cell Lung Cancer

We'll reach out to this number within 24 hrs