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Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

Primary Purpose

Carcinoma, Non Small Cell Lung

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

CT-scan, PET-scan

About this trial

This is an interventional diagnostic trial for Carcinoma, Non Small Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery. Exclusion Criteria: age < 18 years pregnancy

Sites / Locations

Radboud University Nijmegen Medical CentreRecruiting

Outcomes

Primary Outcome Measures

Histological validation of CT-PET image fusion.

Secondary Outcome Measures

Full Information

NCT ID

NCT00184964

First Posted

September 12, 2005

Last Updated

June 3, 2008

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00184964

Brief Title

Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

Official Title

The Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis With Histological Examination of the Resected Specimen

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

4. Oversight

5. Study Description

Brief Summary

CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis. This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery. The resection specimen will be compared to the preoperative imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non Small Cell Lung

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

CT-scan, PET-scan

Primary Outcome Measure Information:

Title

Histological validation of CT-PET image fusion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery. Exclusion Criteria: age < 18 years pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominic A Schinagl, MD

Phone

+31243614515

d.schinagl@rther.umcn.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Bussink, MD, PhD

Organizational Affiliation

Radiation oncologist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

Official's Role

Study Director

Facility Information:

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6500HB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominic A Schinagl, MD

Phone

+31243614515

d.schinagl@rther.umcn.nl

First Name & Middle Initial & Last Name & Degree

Dominic A Schinagl, MD

12. IPD Sharing Statement

Learn more about this trial

Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis

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