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

• Conditions: Lung Cancer; Pancreatic Cancer
• Interventions: Other: C11-Erlotinib PET/CT

• Registration Number: NCT01717807
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-28
• Study First Submitted QC: 2012-10-28
• Last Update Submitted: 2012-10-28
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30
• Study Start: 2013-04
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lung cancer; advanced pancreatic cancer	C11-Erlotinib PET/CT	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
size of tumor and metastasis (mm)

Trial Locations

Locations (1)

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel