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

Lung Cancer Clinical Trial

— EGFR; PET/CT  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01717807
• Other study ID #: 0365-12-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2012
• Last updated: October 28, 2012
• Start date: April 2013

Study information

• Verified date: October 2012
• Source: Hadassah Medical Organization
• Contact: Marina Orevi, MD
• Email: marinaor[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• C11-Erlotinib PET/CT

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment
Secondary	size of tumor and metastasis (mm)