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Pilot Study of Radiologic-Pathologic Correlation in Lung Tumors Based on Core Needle Biopsy


N/A
18 Years
N/A
Not Enrolling
Both
Lung Neoplasm

Thank you

Trial Information

Pilot Study of Radiologic-Pathologic Correlation in Lung Tumors Based on Core Needle Biopsy


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Ernest Scalzetti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

State University of New York - Upstate Medical University

Authority:

United States: Institutional Review Board

Study ID:

SUNYUMU 5376

NCT ID:

NCT00638625

Start Date:

January 2010

Completion Date:

February 2011

Related Keywords:

  • Lung Neoplasm
  • Needle biopsy
  • CT Scan
  • Lung Tumor
  • Lung Mass
  • Neoplasms
  • Lung Neoplasms

Name

Location

SUNY Upstate Medical University Syracuse, New York  13210