To evaluate interlesional and intralesional differences in [11C]erlotinib uptake in EGFR mutated (EGFR+) NSCLC patients who are at different stages in their TKI treatment. To correlate tumor [11C]erlotinib uptake to EGFR mutational status, tumor…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
We previously labeled erlotinib, an epidermal growth factor receptor (EGFR)
tyrosine kinase inhibitor (TKI), with the positron emitter C-11, and showed in
a positron emission tomography (PET) study that [11C]erlotinib accumulation in
non-small cell lung cancer (NSCLC) tumors could be quantified in patients both
on and off erlotinib therapy. In TKI-naïve patients [11C]erlotinib was shown to
be correlated with EGFR mutational status and tumor response to erlotinib
therapy. However, it is well known that intralesional and interlesional EGFR
expression and mutation within one patient may be different. And, this may
change during TKI treatment. To study this interlesional and intralesional
heterogeneity of tumor sensitivity to TKI, whole body PET scans are essential.
Study objective
To evaluate interlesional and intralesional differences in [11C]erlotinib
uptake in EGFR mutated (EGFR+) NSCLC patients who are at different stages in
their TKI treatment. To correlate tumor [11C]erlotinib uptake to EGFR
mutational status, tumor metabolic activity (using [18F]FDG PET) and radiologic
tumor response to TKI therapy.
Study design
An observational study.
Study burden and risks
A venous cannula will be inserted. The total amount of blood withdrawn will be
no more than 21 mL (3x7mL) and 42 mL (6x7mL) in patients without and with
erlotinib therapy, respectively. The total amount of radiation burden (form CT
thorax and PET scan together) will be approximately 5 mSv. The overall
procedure time will be approximately 1.5 hours.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-001518-86-NL |
| CCMO | NL53111.029.15 |