NCT00004138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Sep 1999

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

3.3 years

First QC Date

December 10, 1999

Last Update Submit

July 12, 2016

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancersquamous cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung canceradenocarcinoma of the lungbronchoalveolar cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with negative findings from FDG-PET scan

    Up to 1 month post-FDG-PET scan

Secondary Outcomes (1)

  • Proportion of false-positive lesions found by FDG-PET

    Up to 6 months post-surgery

Study Arms (1)

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.

Procedure: positron emission tomographyProcedure: radionuclide imagingRadiation: fludeoxyglucose F 18

Interventions

positron emission tomographyPROCEDURE
FDG-PET scan + surgery
radionuclide imagingPROCEDURE
FDG-PET scan + surgery
fludeoxyglucose F 18RADIATION
FDG-PET scan + surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +5 more criteria

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Morton Plant Mease Health Care

Clearwater, Florida, 33756, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805-4500, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Veterans Affairs Medical Center - Iowa City

Iowa City, Iowa, 52246-2208, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201-1590, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Westmoreland Hospital

Greensburg, Pennsylvania, 15601-2282, United States

Location

Jameson Memorial Hospital

New Castle, Pennsylvania, 16105, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84143, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Related Publications (2)

  • 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.

    PMID: 18355490RESULT

  • 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.

    PMID: 14688710RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Carolyn E. Reed, MD

    Medical University of South Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

US(23)