C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR). (EGFR; PET/CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717807
Recruitment Status : Unknown
Verified October 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : October 30, 2012
Last Update Posted : October 30, 2012
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.

New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)

Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.

Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.

The purposes of the study are:

  1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
  2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.

Condition or disease Intervention/treatment
Lung Cancer Pancreatic Cancer Other: C11-Erlotinib PET/CT

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
lung cancer; advanced pancreatic cancer Other: C11-Erlotinib PET/CT

Primary Outcome Measures :
  1. Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment

Secondary Outcome Measures :
  1. size of tumor and metastasis (mm)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
oncological patients with NSC type of lung cancer and with advanced pacreatic cancer.

Inclusion Criteria:

  • patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
  • patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.

Exclusion Criteria:

  • lack of histological diagnosis;
  • not a candidate for erlotinib;
  • pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717807

Contact: Marina Orevi, MD
Contact: Eyal Mishani, Phd

Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Marina Orevi, MD   
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization Identifier: NCT01717807     History of Changes
Other Study ID Numbers: 0365-12-HMO
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012

Keywords provided by Hadassah Medical Organization:
epithelial growth factor receptors
lung cancer
advanced tumor of pancrease
C11-Erlotinib PET/CT

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators