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

NCT01717807 | Unknown

• 1 other identifier: 0365-12-HMO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 2.To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.

Conditions

Lung Cancer; Pancreatic Cancer

Keywords

epithelial growth factor receptors; lung cancer; advanced tumor of pancrease; erlotinib; C11-Erlotinib PET/CT

Outcome Measures

Primary Outcomes (1)

• Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment

Secondary Outcomes (1)

• size of tumor and metastasis (mm)

Study Arms (1)

lung cancer; advanced pancreatic cancer

Other: C11-Erlotinib PET/CT

Interventions

C11-Erlotinib PET/CT OTHER

lung cancer; advanced pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Lung Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marina Orevi, MD

CONTACT

marinaor@hadassah.org.il

Eyal Mishani, Phd

CONTACT

eyalmi@ekmd.huji.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: October 30, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

IL (1)