NCT01482182

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

November 17, 2011

Last Update Submit

November 17, 2015

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancerDiffusion-weighted MRI18F-FDG PETTreatment responsePrognosis

Outcome Measures

Primary Outcomes (1)

  • DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis

    The primary endpoint of this study is the prediction of one-year overall survival by monitoring the metabolic and functional responses of the tumor following one cycle of chemotherapy.

    one year

Secondary Outcomes (2)

  • Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis

    one year

  • Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis

    one year

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with advanced NSCLC

You may qualify if:

  • 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

You may not qualify if:

  • Pure bronchioloalveolar cell carcinoma histology
  • Poorly controlled diabetes
  • Prior malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ho Yun Lee, Dr.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 30, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-10

Locations

KR(1)