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)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01717807
First received: October 28, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention
Lung Cancer
Pancreatic Cancer
Other: C11-Erlotinib PET/CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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:
  • size of tumor and metastasis (mm)

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
lung cancer; advanced pancreatic cancer Other: C11-Erlotinib PET/CT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

oncological patients with NSC type of lung cancer and with advanced pacreatic cancer.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717807

Contacts
Contact: Marina Orevi, MD marinaor@hadassah.org.il
Contact: Eyal Mishani, Phd eyalmi@ekmd.huji.ac.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Marina Orevi, MD       marinaor@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01717807     History of Changes
Other Study ID Numbers: 0365-12-HMO
Study First Received: October 28, 2012
Last Updated: October 28, 2012
Health Authority: Israel: Institutional Review Board

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

Additional relevant MeSH terms:
Lung Neoplasms
Pancreatic Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Mitogens
Erlotinib
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014