Lung NeoplasmNCT00638625
Correlation of X-ray and Pathology With Needle Biopsy of Lung Tumors
An observational study of Lung Neoplasm, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Vulnerable populations will be excluded.
- Subjects who lack the capacity to provide consent
- Subjects who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Pilot Study of Radiologic-Pathologic Correlation in Lung Tumors Based on Core Needle Biopsy
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.
Read the 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.
- Conditions
- Lung Neoplasm
- Keywords
- Needle biopsy, CT Scan, Lung Tumor, Lung Mass
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Due to specimen collection difficulties; this study has been terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernest Scalzetti, State University of New York - Upstate Medical University
- Investigators
- Ernest Scalzetti, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638625
- Sponsor's protocol ID
- SUNYUMU 5376
- Status last verified
- May 2015
- First submitted
- 12 Mar 2008
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Radiologic-Pathologic Correlation in Lung Tumors Based on Core Needle Biopsy
- ClinicalTrials.gov ID
- NCT00638625
- Acronym / sponsor ID
- SUNYUMU 5376
- Conditions
- Lung Neoplasm
- Keywords
- Needle biopsy, CT Scan, Lung Tumor, Lung Mass
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to specimen collection difficulties; this study has been terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Vulnerable populations will be excluded.
- Subjects who lack the capacity to provide consent
- Subjects who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of the accuracy of registration of contrast-enhanced CT images to the CT images that show the location of the core tissue sample
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Scalzetti, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.