PET Response During Chemoradiation of Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02315053|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Other: Low dose FDG PET/CT 5 x.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dynamic FDG‐PET/CT Response During Chemoradiation for NSCLC|
|Actual Study Start Date :||March 21, 2013|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Low dose FDG PET/CT 5x
Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).
Other: Low dose FDG PET/CT 5 x.
Multiple FDG PET/CT studies will be added to the normal diagnostic procedures as a part of this study, with the number of scans depending on the study stage, to a maximum of 6 per patient.
Other Name: No treatment intervention but diagnostic intervention.
- maximum FDG uptake (SUVmax) [ Time Frame: 1 Year ]• A main study parameter is the maximum FDG uptake (SUVmax (maximum Standardized Uptake Value)) at the location of the primary tumour, as determined at multiple days during treatment (with a maximum of five time points per patient), expressed as T50 for response evaluation.
- SUVmax during the first two weeks of treatment, indicating inflammatory response. [ Time Frame: First Two weeks of treatment ]• Increase SUVmax during the first two weeks of treatment, indicating inflammatory response.
- SUVmax in the two weeks prior to treatment, indicating progression [ Time Frame: Two weeks prior to treatment ]• Increase SUVmax between diagnostic imaging and start of treatment, indicating potential progression.
- Progression free survival [ Time Frame: 1 Year ]• Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.
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): NCT02315053
|The Netherlands Cancer Institute|
|Amsterdam, Noord Holland, Netherlands, 1066CX|
|Principal Investigator:||Wouter Vogel, MD,PhD||NKI|