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Predictive Value of FDG PET/CT, DWI and DCE-MRI Scans for Non-small Cell Lung Cancer Patients Receiving Chemotherapy

NCT ID: NCT01482182

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-01-31

Brief Summary

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In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer (NSCLC).

Detailed Description

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Study cohort will undergo PET/CT and MRI scans prior to chemotherapy and after the first chemotherapy cycle. MRI scans include DCE-MRI and DWI. The following parameters will be calculated using these values:

1. Metabolic parameters on FDG-PET A. SUV change ratio (SCR) = SUVpost/SUVpre B. MTV change ratio (VCR) = MTVpost/pre C. TLG change ratio = SCR X VCR
2. Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve
3. Diffusion parameters on DWI A. Mean ADC B. fDM

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Histologically proven NSCLC
* Newly diagnosed Stage stage IV
* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy
* At least one measurable primary or other intrathoracic lesion \>= 2cm, according to RECIST
* Performance status of 0 to 2 on the ECOG scale
* Age 18 years or older
* Able to tolerable PET/CT and MRI imaging required by protocol
* Able to give study-specific informed consent

Exclusion Criteria

* Pure bronchioloalveolar cell carcinoma histology
* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study
* Poorly controlled diabetes
* Prior malignancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho Yun Lee, Dr.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-05-087

Identifier Type: -

Identifier Source: org_study_id