[11C]Erlotinib tumor heterogeneity: an in vivo study using static whole body positron emission tomography in non-small cell lung cancer patients.

Completed

• Conditions: lung cancer; non-small cell lung carcinoma; 10038666

• Registration Number: NL-OMON44987
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Three groups of 10 evaluable patients, i.e. 30 evaluable patients, with histologically proven NSCLC, with an activating EGFR mutation as assessed by HRM and DNA-sequencing;- Three groups are:;1. Patients who were never treated with TKI, planned to receive TKI therapy. ;2. Patients who relapse under TKI therapy, planned to stop TKI therapy;3. Patients who relapsed after second line cytotoxic chemotherapy and are planned for TKI retreatment. ;- Age between 18 and 70 years;- Life expectancy of at least 12 weeks;- Malignant lesions (at least 2) of at least 1.5 cm diameter as measured by CT ;- Karnofsky index ><=60%;- Written informed consent

Exclusion Criteria

- Claustrophobia;- Pregnant or lactating patients;- Concurrent treatment with experimental drugs

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tumor-to-blood ratio (TBR) measures of [11C]erlotinib uptake in tumors and<br /><br>metastases<br /><br>Correlation between TBR form different lesions and parts of tumor lesions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Correlation of tumor TBR with EGFR mutational status<br /><br>Correlation of TBR in tumors and metastases with [18F]FDG standardized uptake<br /><br>values (SUV)<br /><br>Correlation of tumor TBR with radiologic changes under TKI therapy (using<br /><br>RECIST)</p><br>