Positron Emission Tomography for Detecting Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004138
• Other study ID #: ACOSOG-Z0050
• Secondary ID: CDR0000067368
• Status: Completed
• Phase: N/A
• First received: December 10, 1999
• Last updated: July 12, 2016
• Start date: September 1999
• Est. completion date: December 2002

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 lung cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• positron emission tomography

• radionuclide imaging

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Westmoreland Hospital	Greensburg	Pennsylvania
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	Lakeland Regional Medical Center	Lakeland	Florida
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Jameson Memorial Hospital	New Castle	Pennsylvania
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Lutheran General Hospital	Park Ridge	Illinois
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Cancer Institute	Pittsburgh	Pennsylvania
United States	Massey Cancer Center	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View 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 Z0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with negative findings from FDG-PET scan		Up to 1 month post-FDG-PET scan	No
Secondary	Proportion of false-positive lesions found by FDG-PET		Up to 6 months post-surgery	No