A Pilot Study of 18F FLT PET/CT in Evaluating Early Response to Anti-Proliferative Therapies in Non Small Cell Lung Cancer and Thymic Tumors
- (18)F FLT, a thymidine analog, has uptake in tumors that correlates with proliferative
rates and may be an early predictor of tumor response.
- Due to uptake in inflammatory tissues, routinely used (18)F FDG PET/CT is often unable
to distinguish therapeutic response from reactive change early in therapy.
- Molecularly targeted therapies relating to the MEK kinase pathway in non small cell
lung cancer (NSCLC) and the IGF pathway (anti-IGF-1R monoclonal antibodies) in thymoma,
affect tumor proliferation.
- We intend to explore the potential utility of (18)F FLT PET/CT imaging as an early
marker of therapeutic response in molecularly targeted therapies relating to the MEK
kinase pathway in NSCLC and the IGF pathway in thymic tumors.
-To explore the relationship between change in (18)F FLT tumor uptake (pre-treatment and
soon after initiation of treatment (2 weeks)) and progression free survival in NSCLC
patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab
- Subjects with pathology proven lung cancer or thymoma enrolled in an NCI therapy
- Participant must be 18 years or older and have ECOG Performance of less than or equal
- Patients must have measurable disease by RECIST criteria.
- Patients must have the ability to provide informed consent. All subjects must sign a
document of informed consent indicating their understanding of the investigational
nature and risks of the study before any protocol related studies are performed.
-This is a pilot study which will incorporate (18)F FLT and (18)F FDG PET/CT imaging
sessions prior to therapy with AZD6244, Selumetinib, in NSCLC and IMC-A12, Cixutumumab, in
thymoma, and 2 weeks (+/- 4 days) following therapy initiation. The imaging parameters will
be evaluated with respect to clinical response (as determined under the referring protocol).
We expect to enroll 24 evaluable patients in this single center study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To explore the relationship between change in 18F FLT tumor uptake and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab
Maria Liza Lindenberg, M.D.
National Cancer Institute (NCI)
United States: Federal Government