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A study of radioactive afatinib, [18F]afatinib, in lung cancer patients, to evaluate its uptake in tumors and its predictive value to identify patients who will respond to afatinib therapy


- candidate number21986
- NTR NumberNTR5203
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2015
- Secondary IDsNL46671.029.13 
- Public TitleA study of radioactive afatinib, [18F]afatinib, in lung cancer patients, to evaluate its uptake in tumors and its predictive value to identify patients who will respond to afatinib therapy
- Scientific TitleCan tumor uptake of [18F]afatinib in NSCLC patients be quantified, and does [18F]afatinib uptake identify patients who will benefit from afatinib therapy ?
- ACRONYM
- hypothesisthe tumor uptake of [18F]afatinib will be able to predict afatinib-sensitive tumors
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC), EGFR mutation
- Inclusion criteria- Age18-70 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- 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 below lower limit of normal)
- Coumarin therapy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mei-2015
- planned closingdate1-mei-2017
- Target number of participants20
- InterventionsThere will be 4 subsequent steps involving 4, 8 and 8 patients, respectively, in order to find the optimal PET scanning conditions.

Step 0: Dosimetry. We will follow the published methods for assessing radiation safety of an [18F]-labeled PET traces for first-in-human studies. A single subject will undergo 4 whole-body PET scans using a 74 MBq dose, to test if [18F]afatinib disproportionately accumulates in a single radiosensitive organ. If, as expected, it does not, then the next step will be performed.

Step 1: The first 4 patients will undergo a low dose CT scan, followed by a dynamic [15O]H2O PET scan and thereafter a prolonged (90 + 30 minutes) dynamic [18F]afatinib PET scan. Arterial sampling will be performed. After step 1, kinetic analysis of the prolonged dynamic PET data will be performed to determine the best scanning interval for a whole body static PET scan.

Step 2: The subsequent 8 patients (regardless of the groups they are in) will undergo 2 scanning procedures on subsequent days for determining test-retest repeatability. A low dose CT scan, followed by a dynamic [15O]H2O PET scan and thereafter a 60-min dynamic [18F]afatinib PET scan will be done, followed by a break (duration will be determined by step 1). After this, a low dose CT and a 40-min static [18F]afatinib whole body PET scan will be made. Arterial sampling will be performed. After step 2, a preliminary analysis will be performed to determine the optimal kinetic model, find the corresponding measure of uptake, assess test-retest repeatability, assess whether arterial blood sampling is still needed, and evaluate the validity of simplified parameters (e.g. SUV) obtained with whole body scans.

Step 3: The final 8 patients will only undergo a low dose CT scan, followed by a [15O]H2O dynamic PET scan and thereafter a 60-min dynamic [18F]afatinib PET scan, followed by a break, a low dose CT and a 40-min static [18F]afatinib whole body PET scan. Venous and arterial blood samples will be drawn.
- Primary outcome1. To define the optimal pharmacokinetic tracer model for [18F]afatinib.

2. To determine the optimal simplified measure for quantifying tumor [18F]afatinib uptake

3. To assess [18F]afatinib uptake differences between patients (1) with wild type EGFR, (2) EGFR mut+, TKI-resistant EGFR mut+ (3) with and (4) without T790M mutations.

4. To assess whether [18F]afatinib uptake is predictive for tumor response to afatinib in patients with wild type EGFR and EGFR mut+, prior to TKI therapy and after resistance occurs to a 1st generation TKI.
- Secondary outcomesame as primary
- Timepointsas stated in the intervention section: 3 steps in 2 years
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Iris Bahce
- CONTACT for SCIENTIFIC QUERIESMD Iris Bahce
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Boehringer Ingelheim
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-apr-2015 - 25-jul-2015


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