Can tumor uptake of [18F]afatinib in NSCLC patients be quantified, and does [18F]afatinib uptake identify patients who will benefit from afatinib therapy ?

Can tumor uptake of [18F]afatinib in NSCLC patients be quantified, and does [18F]afatinib uptake identify patients who will benefit from afatinib therapy ? - [18F]afatinib in NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47284

Enrollment

Registered

2013-11-04

Start date

2015-04-17

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

lung cancer lung carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age above 18 years - Patient is planned to receive afatinib after scanning - Histologically proven NSCLC, with EGFR mutational status (as determined by high resolution melting and DNA sequencing) - Life expectancy of at least 12 weeks - Malignant lesion of at least 1.5 cm diameter within the chest as measured by CT - Performance status Karnofsky index >60% - Written informed consent

Exclusion criteria

Exclusion criteria: - Claustrophobia - Pregnant or lactating patients - Patients having metal implants in the thorax that could cause an attenuation artefact (e.g. pacemakers) - Concurrent treatment with experimental drugs - Anaemia (Hb

Design outcomes

Primary

Measure	Time frame
1. Tracer pharmacokinetic modeling for [18F]afatinib. 2. Procedure optimization 3. Difference between tumor [18F]afatinib uptake and EGFR mutational status 4. Correlation between tumor [18F]afatinib uptake and tumor response to afatinib therapy using RECIST 1.1.	—

Secondary

Measure	Time frame
N.a.	—

Countries

Netherlands

Outcome results