Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
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
Background:
- Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans
are used to detect tumor responses to cancer treatment. However, it may be difficult to
detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These
scans cannot easily show a difference between remaining cancer cells and inflammation.
Researchers want to try a new PET/CT scan tracer that may be able to show the difference
between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are still
actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are responding to
early stages of treatment.
Objectives:
- To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer
response to treatment.
Eligibility:
- Individuals at least 18 years of age who are being treated for lung cancer or thymoma.
Design:
- Participants will be screened with a physical exam and medical history. Blood, urine,
and tumor tissue samples will be collected.
- Participants will have two PET/CT scans on separate days before starting chemotherapy.
One scan will be with a standard radiotracer. The other will be with the 18F-FLT tracer.
- About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT scans
on separate days. Additional blood samples will be collected at this time.
Background:
- (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.
Objectives:
-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
Eligibility:
- Subjects with pathology proven lung cancer or thymoma enrolled in an NCI therapy
protocol.
- Participant must be 18 years or older and have ECOG Performance of less than or equal to
2.
- 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.
Design:
-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.
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