Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
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|ClinicalTrials.gov Identifier: NCT01476085|
Recruitment Status : Terminated (Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented)
First Posted : November 22, 2011
Last Update Posted : July 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Radiation: ML10||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
No Intervention: no treatment
[18F]ML10 radioligand apoptosis biomarker
- changes in [18F]ML10 uptake in tumours [ Time Frame: between baseline at day 0 and between 14-20 days after ]Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
- alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes [ Time Frame: between baseline at day 0 and between 14-20 days after ]Relationship between alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes in response to chemotherapy as measured by standard of care CT scan and FDG PET scan.
- voxel-based uptake map of [18F]ML10 in the target lesion [ Time Frame: between baseline at day 0 and between 14-20 days after ]Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.
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): NCT01476085
|GSK Investigational Site|
|London, United Kingdom, W12 0NN|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|