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Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC

NCT ID: NCT01889212

Last Updated: 2016-10-28

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

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

11C-erlotinib PET/CT

Intervention Type OTHER

Interventions

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11C-erlotinib PET/CT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* pregnancy
* severe dyspnoea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Meldgaard, Ph.D MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Deparment of oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/22095231

Related Info

Other Identifiers

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1-10-72-19-12

Identifier Type: -

Identifier Source: org_study_id