Lung CancerEGFR; PET/CTNCT01717807
C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).
An observational study of Lung Cancer and Pancreatic Cancer, run by Hadassah Medical Organization at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pancreatic Cancer
- What is being tested?
- C11-Erlotinib PET/CT
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: oncological patients with NSC type of lung cancer and with advanced pacreatic cancer.
Who may be able to join
- 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.
Who cannot join
- lack of histological diagnosis;
- not a candidate for erlotinib;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Marina Orevi, MD contact
Eyal Mishani, Phd contact
Israel1 site
Hadassah Hebrew University Medical Center
Jerusalem, 91120
Marina Orevi, MD, marinaor@hadassah.org.il
About this study
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.)
Read more
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.
- Conditions
- Lung Cancer, Pancreatic Cancer
- Being tested
- C11-Erlotinib PET/CT
- Keywords
- epithelial growth factor receptors, lung cancer, advanced tumor of pancrease, erlotinib, C11-Erlotinib PET/CT
- Medical subject headings
- Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C11-Erlotinib PET/CTOther
| Study group | Role | What they receive |
|---|---|---|
| lung cancer; advanced pancreatic cancer | Not described Receives: Other: C11-Erlotinib PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717807
- Sponsor's protocol ID
- 0365-12-HMO
- Acronym
- EGFR; PET/CT
- Status last verified
- Oct 2012
- First submitted
- 28 Oct 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).
- ClinicalTrials.gov ID
- NCT01717807
- Acronym / sponsor ID
- EGFR; PET/CT / 0365-12-HMO
- Conditions
- Lung Cancer, Pancreatic Cancer
- Keywords
- epithelial growth factor receptors, lung cancer, advanced tumor of pancrease, erlotinib, C11-Erlotinib PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer; advanced pancreatic cancer | – | Other: C11-Erlotinib PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- oncological patients with NSC type of lung cancer and with advanced pacreatic cancer.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- lack of histological diagnosis;
- not a candidate for erlotinib;
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C11-Erlotinib PET/CT | Other | lung cancer; advanced pancreatic cancer |
Primary outcome
Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment
1 secondary outcome
size of tumor and metastasis (mm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Orevi, MD contact
Eyal Mishani, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Pancreatic Cancer, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Orevi, MD (marinaor@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.