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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44987
Enrollment
30
Registered
2015-11-16
Start date
2016-06-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer non-small cell lung carcinoma

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 >

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Tumor-to-blood ratio (TBR) measures of [11C]erlotinib uptake in tumors and metastases Correlation between TBR form different lesions and parts of tumor lesions

Secondary

MeasureTime frame
Correlation of tumor TBR with EGFR mutational status Correlation of TBR in tumors and metastases with [18F]FDG standardized uptake values (SUV) Correlation of tumor TBR with radiologic changes under TKI therapy (using RECIST)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)