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

This study has been terminated.
(Due to specimen collection difficulties; this study has been terminated)
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00638625
First received: March 12, 2008
Last updated: April 26, 2011
Last verified: January 2010
  Purpose

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.


Condition
Lung Neoplasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Radiologic-Pathologic Correlation in Lung Tumors Based on Core Needle Biopsy

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Determination of the accuracy of registration of contrast-enhanced CT images to the CT images that show the location of the core tissue sample [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Newer cross-sectional imaging methods allow improved visualization of anatomic detail—for example, high-resolution CT has a spatial resolution of less than 1 mm in all 3 dimensions. These imaging methods also provide a limited amount of physiologic information—for example, tumor perfusion as demonstrated by enhancement with intravenous contrast agents. Radiologic-pathologic correlation in the current era gives us the opportunity to work on a finer spatial scale and to take advantage of the additional physiologic information. Pathologic assessment of tissue has evolved at the same time. Tissue can be stained in the traditional way for microscopic evaluation but newer tools such as immunohistochemistry and, most recently, methods of molecular biology can be applied as well.

We are interested in radiologic-pathologic correlation in lung tumors. Tumors are known to be heterogeneous; we want to develop an approach that will allow us to explore their spatial organization. We cannot rely on surgical resection to provide tissue for pathologic evaluation, because the majority of lung lesions never come to resection. For example, only ~15% of lung cancer patients are surgical candidates. The remainder would be lost to the classical approach that depends on surgery. Percutaneous needle biopsy provides an alternative means of tissue sampling. This is a safe, effective and commonly used way to obtain samples of tissue ("core samples") from any given lung mass. The pathologist can process these core samples in the same way as a surgical specimen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Vulnerable populations will be excluded.
  • Subjects who lack the capacity to provide consent
  • Subjects who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638625

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Ernest Scalzetti, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Ernest Scalzetti, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00638625     History of Changes
Other Study ID Numbers: SUNYUMU 5376
Study First Received: March 12, 2008
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Needle biopsy
CT Scan
Lung Tumor
Lung Mass

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014