Correlation of X-ray and Pathology With Needle Biopsy of Lung Tumors

NCT00638625 | Withdrawn

• 1 other identifier: SUNYUMU 5376
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the features that the pathologist sees, when examining a lung tumor under the microscope, to the way that the tumor appears on the computed tomography (CT) scan. Features of the tumor may include abnormal blood vessels and areas in which tumor cells are dying. The samples that are taken during the needle biopsy contain information from one small part of the tumor. The investigators believe that they can show where in the tumor the samples came from, based on the CT scans during the biopsy procedure. If the investigators can accurately determine where in the tumor their samples came from, they can compare the features of that part of the tumor, as seen on the CT images, to the features of that part of the tumor as seen under the microscope. This research study also will give the investigators an idea of how much the biopsy samples are distorted in the process of preparing them for examination under the microscope.

Conditions

Lung Neoplasm

Keywords

Needle biopsy; CT Scan; Lung Tumor; Lung Mass

Outcome Measures

Primary Outcomes (1)

• Determination of the accuracy of registration of contrast-enhanced CT images to the CT images that show the location of the core tissue sample

Secondary Outcomes (1)

• Determination of the dimensional stability of the core tissue sample: whether, and if so, how much, the length of the core sample changes as it is processed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be recruited among patients who are referred for percutaneous needle biopsy of a suspected malignant lesion in the lung. Consecutive patients who meet the eligibility criteria will be offered enrollment until the study accrual target has been met.

You may qualify if:

• Subjects who have a lung tumor that is likely to be malignant
• Subjects who have been referred for percutaneous needle biopsy
• The target lesion must be at least 10 mm in short-axis dimension.
• Subjects must have intravenous access.
• No history of significant allergy to intravenous contrast.
• Subjects must have sufficient renal function to receive intravenous contrast for enhancement of the CT images.

You may not qualify if:

• Vulnerable populations will be excluded.
• Subjects who lack the capacity to provide consent
• Subjects who are pregnant

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ernest Scalzetti, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: January 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

US (1)