An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries (PERTAIN)
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|ClinicalTrials.gov Identifier: NCT02247713|
Recruitment Status : Unknown
Verified September 2014 by The Netherlands Cancer Institute.
Recruitment status was: Not yet recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
|Condition or disease|
|Non Small Cell Lung Cancer Stage III|
|Study Type :||Observational|
|Estimated Enrollment :||520 participants|
|Official Title:||An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2017|
Participating centers will retrospectively provide demographic, tumor, treatment and follow-up details on at least 25 consecutive patients with stage III NSCLC previously treated with curative intent chemoradiotherapy (concurrent or sequential) in the period between 2010 and 2013.
Participating centers will provide prospective data on patients with stage III NSCLC treated with curative intent concurrent chemoradiotherapy. Centers will be asked to include at least 25 consecutive cases following the training intervention and the successful local implementation of PET/CT for RTP in NSCLC.
- 2-year overall survival [ Time Frame: the included patients will be followed for a maximum of 2 years ]Determine the impact of PET/CT in RTP on 2-year overall survival rates for patients with stage III NSCLC receiving chemoradiotherapy with curative intent. Patients from the retrospective cohort will be selected from the institutional database and were treated between 2010 to 2013. Patients from the prospective cohort will be selected until the end of 2015.
- Observer agreement with expert contours as a measure of the effect of a training intervention on tumor volume delineation [ Time Frame: up to 5 months ]Determine the impact of a PET/CT in RTP training intervention on tumor volume delineation for stage III NSCLC radiotherapy. Different parameters are used to determine the observer variation: Dice Index, median surface distances
- Baseline PET/CT characteristics as a measure for PET/CT scanner performance [ Time Frame: up to 8 months ]Determine the quality of PET/CT scanners. Study baseline PET/CT imaging protocols and image acquisition characteristics with the following parameters: recovery coefficients, spatial resolution measurement, and calibration of SUV determination. All centers will participate in the EARL accreditation programme.
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): NCT02247713
|Contact: Tom Konert, BScemail@example.com|
|Principal Investigator:||Wouter V Vogel, MD||Antoni van Leeuwenhoek - Netherlands Cancer Institute|
|Principal Investigator:||Gerard G Hanna, MD||Centre for Cancer Research and Cell Biology, Queen's University Belfast|