Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT (SBRT FLT-PET)
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|ClinicalTrials.gov Identifier: NCT02456246|
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : June 11, 2019
Stereotactic body radiotherapy (SBRT) has emerged as one of the leading curative method for early stage non-small cell lung cancer (NSCLC). However, assessing the status of the disease during post-SBRT follow up presents a challenge. Currently, chest Computed Tomography (CT) is the main technique to detect whether cancer has come back, but this method has demonstrated poor accuracy and reliability in determining if the observed post-operative lung changes are benign or malignant.
Positron-emission tomography (PET) is an imaging technique that uses special radioactive tracers to cell growth. The use of PET scans with a tracer that target the pathways of DNA synthesis may be more accurate than CT for detecting if the cancer has come or not.
The purpose of this study is to see if a PET radiotracer called 18F-FLT (3'-deoxy-3'-fluorothymidine) can identify cancer recurrences accurately compared to regular CT scans.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer (NSCLC)||Procedure: FLT-PET||Not Applicable|
Stereotactic body radiotherapy (SBRT) has demonstrated an impressive 3-year control rate of higher than 90% for early stage NSCLC, leading to increased use of this technique as a curative method for lung cancer treatment. With growing clinical experience with this technique, post-SBRT follow up has received more attention. Follow up after SBRT is done primarily by thorax CT, which is affected by radiation-induced radiographic lung changes that can resemble or obscure local recurrence.
FLT (3'-deoxy-3'-fluorothymidine) is a thymidine analogue which is non-toxic in tracer doses, and can be labeled with 18F. FLT-PET is a type of imaging (similar concept to the widely used 18-FDG PET-CT) that is based on integration of thymidine into DNA for assessment of proliferation. Conceptually, increased DNA synthesis is correlated to tumor aggressiveness and response to therapy, more so than glucose utilization - as in FDG-PET could be.
The purpose of this study is therefore to see what added information the use of FTL-PET can provide in distinguishing between changes in the lung that occur as a result of treatment that are not cancerous and those that are due to recurrence or progressive disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Positron emission tomography scan using the 18f-FLT (3'deoxy-3'-fluorothymidine) tracer
- To report the SUVmax for the three cohorts [ Time Frame: 1 year ]
- To compare FLT uptake in 4D (respiratory sorted) versus free breathing FLT-PET scans [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456246
|Contact: Meredith Giuliani, MD||416 946 4501 ext 2983||Meredith.Giuliani@rmp.uhn.on.ca|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Meredith Giuliani, MBBS,MD,FRCPC 416 946 4501 ext 2983 Meredith.Giuliani@rmp.uhn.on.ca|
|Principal Investigator:||Meredith Giuliani, MD||UHN|