NCT01619241

Brief Summary

The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

May 24, 2012

Last Update Submit

June 12, 2012

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancerF-18 FLT PET/CT

Outcome Measures

Primary Outcomes (1)

  • overall survival

    from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year

Secondary Outcomes (1)

  • time to progression

    from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year

Study Arms (1)

advanced non-small cell lung cancer

Other: PET/CT

Interventions

PET/CTOTHER

F-18 FLT PET/CT

Also known as: F-18 FLT PET/CT
advanced non-small cell lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

advanced non-small cell lung cancer

You may qualify if:

  • advanced non-small cell lung cancer (stage IIIB, IV)
  • at least one measurable lesion
  • performance status (ECOG) 0-2
  • st-line platinum chemotherapy and no progression

You may not qualify if:

  • mixed small cell and non-small cell
  • uncontrolled brain metastasis
  • previous malignancy within 5 years (except basal cell carcinoma of skin, carcinoma in situ of uterine cervix)
  • pregnant or breast feeding
  • pemetrexed chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ie Ryung Yoo, MD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

  • Jin Hyoung Kang, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woo Hee Choi, MD

CONTACT

82-31-249-8494choiwoohee@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Nuclear Medicine department

Study Record Dates

First Submitted

May 24, 2012

First Posted

June 14, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2015

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

KR(1)