Lung CancerNCT00004138
Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
A study testing positron emission tomography, radionuclide imaging and fludeoxyglucose F 18 in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 23 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- positron emission tomography, radionuclide imaging and fludeoxyglucose F 18
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 1999to Dec 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 20Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201-1590
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Morton Plant Mease Health Care
Clearwater, Florida, 33756
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Westmoreland Hospital
Greensburg, Pennsylvania, 15601-2282
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
Veterans Affairs Medical Center - Iowa City
Iowa City, Iowa, 52246-2208
Lakeland Regional Medical Center
Lakeland, Florida, 33805-4500
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Jameson Memorial Hospital
New Castle, Pennsylvania, 16105
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029-6574
Lutheran General Hospital
Park Ridge, Illinois, 60068
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
Massey Cancer Center
Richmond, Virginia, 23298-0037
William Beaumont Hospital
Royal Oak, Michigan, 48073
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- positron emission tomography, radionuclide imaging, fludeoxyglucose F 18
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomographyProcedure or surgery
radionuclide imagingProcedure or surgery
fludeoxyglucose F 18Radiation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with negative findings from FDG-PET scan
Measured: Up to 1 month post-FDG-PET scan
Secondary outcomes (1)
Proportion of false-positive lesions found by FDG-PET
Measured: Up to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1999
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carolyn E. Reed, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004138
- Sponsor's protocol ID
- ACOSOG-Z0050
- Other IDs
- CDR0000067368
- Status last verified
- Jul 2016
- First submitted
- 10 Dec 1999
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18355490Reed 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.
PubMed 14688710
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00004138
- Acronym / sponsor ID
- ACOSOG-Z0050
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1999
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG-PET scan + surgery | Experimental | Procedure: positron emission tomography, Procedure: radionuclide imaging, Radiation: fludeoxyglucose F 18Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positron emission tomography | Procedure or surgery | FDG-PET scan + surgery |
| radionuclide imaging | Procedure or surgery | FDG-PET scan + surgery |
| fludeoxyglucose F 18 | Radiation | FDG-PET scan + surgery |
Primary outcome
Proportion of patients with negative findings from FDG-PET scan
Time frame: Up to 1 month post-FDG-PET scan
1 secondary outcome
Proportion of false-positive lesions found by FDG-PET
Time frame: Up to 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Results publication: PubMed 18355490Kozower 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 publication: PubMed 14688710Reed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn E. Reed, MD study chair
Medical University of South Carolina
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positron emission tomography, radionuclide imaging and fludeoxyglucose F 18 in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with negative findings from FDG-PET scan (time frame: Up to 1 month post-FDG-PET scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.