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)
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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:
- 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.
- 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 |
- Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment
- 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 |
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.
Contacts and Locations| Contact: Marina Orevi, MD | marinaor@hadassah.org.il | |
| Contact: Eyal Mishani, Phd | eyalmi@ekmd.huji.ac.il |
| Israel | |
| Hadassah Hebrew University Medical Center | Not yet recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Marina Orevi, MD marinaor@hadassah.org.il | |
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 May 21, 2013