3-D Reconstruction of CT Scan Images in the Evaluation of... | NCT00613041

Studies
3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules

NCT00613041

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Undiagnosed Pulmonary Nodules
Lung Nodules

Interventions

CT Scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Nov 3, 2021Actual

Completion Date

Nov 3, 2021Actual

First Submitted Date

Jan 29, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Feb 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2023

Last Update Posted Date

Sep 13, 2023Actual

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with one or more pulmonary nodules 5-15 mm in diameter.	Procedure: CT Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT Scan	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		conclusion of the study

Secondary Outcomes

Measure	Description	Time Frame
To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases.		conclusion of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who meet eligibility criteria will be recruited from the services that comprise the Thoracic Disease Management Team (DMT), specifically the Divisions of Pulmonary Medicine and Thoracic Surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Feinstein, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States