NCT01889212

Brief Summary

New treatment strategies have been developed in lung cancer targeting the Epidermal Growth Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds rates to the treatment and should be treated with a EGFR inhibitor as first line of treatment. Some wild type patients do as well respond but selection of these patients is more difficult. Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer (11C-erlotinib) in tumors has showed promising results for selection of responders. The investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 3, 2013

Last Update Submit

October 27, 2016

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib

    Accumulation of 11c-erlotinib in tumors will be correlated to PFS on erlotinib treatment.

    From date of inclusion until the date of first documented progression on the erlotinib treatment or date of death, whichever came first, assessed up to 30 months

Study Arms (1)

NSCLC, erlotinib treatment, 11C-erlotinib PET/CT

EXPERIMENTAL
Other: 11C-erlotinib PET/CT

Interventions

11C-erlotinib PET/CTOTHER
NSCLC, erlotinib treatment, 11C-erlotinib PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lung Cancer patients with non-small cell histology and stage IV disease who are candidate for erlotinib treatment as first/ second/ third line of treatment

You may not qualify if:

  • pregnancy
  • severe dyspnoea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment of oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Meldgaard, Ph.D MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 28, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 28, 2016

Record last verified: 2013-06

Locations

DK(1)