This trial is active, not recruiting.

Conditions undiagnosed pulmonary nodules, lung nodules
Treatment ct scan
Sponsor Memorial Sloan Kettering Cancer Center
Start date April 2003
End date August 2016
Trial size 19 participants
Trial identifier NCT00613041, 03-039


In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called "nodules", which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years.

Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause.

Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with one or more pulmonary nodules 5-15 mm in diameter.
ct scan
All patients will undergo serial CT scans after 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months as is standard care. Nodules are to be scanned at 2.5mm collimation / 1.25 mm reconstruction. This resolution is necessary for volume measurements of nodules less than 1cm in diameter.

Primary Outcomes

To collect preliminary data regarding the comparative sensitivity and specificity of conventional CT scan and three-dimensional CT for detecting the growth of nonspecific pulmonary nodules.
time frame: conclusion of the study

Secondary Outcomes

To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases.
time frame: conclusion of the study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules. - History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked). - Age >18 - Nodule size 5 to 15 mm in diameter. Exclusion Criteria: - Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS) - Active lung cancer or metastasis to the lung. - Contraindication to needle biopsy. - Pneumonectomy - Need for supplemental oxygen. - Radiation pneumonitis - Interstitial lung disease.

Additional Information

Official title Pilot Study: 3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules
Principal investigator Marc Feinstein, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.