Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria (CRIPNET)
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|ClinicalTrials.gov Identifier: NCT02841865|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : January 26, 2018
The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor size, has been considered as a reproducible method that facilitates not only the measurement of the mass but the evaluation of response to given treatments; while classic chemotherapy induces a reduction of the tumor, new target therapies frequently produce the stabilization of the disease or a delayed progression. These new therapeutic alternatives have shade light on the limitations of the RECIST criteria, since the response to these type of treatments are basically associated with changes on the radiological characteristics of the tumor, as well as other findings in functional imaging.
This study is aimed to compare the response rates according both Choi and RECIST criteria.
|Condition or disease|
|Pancreatic Neuroendocrine Tumors|
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||Evaluation of Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
- Response to treatment [ Time Frame: 3 months ]According Choi and RECIST Criteria
- Progression Free Survival on partial response [ Time Frame: 3 months ]Time between start of treatment and progression of disease in patients with partial response
- Progression Free Survival on Stable Disease [ Time Frame: 3 months ]Time between start of treatment and progression of disease in patients with stable disease
- Impact of Tumor Uptake on Response to Treatment [ Time Frame: 3 months ]Description of the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase (baseline evaluation), and assessment of a possible correlation with the response to treatment using the RECIST criteria.
- Impact of Response to Treatment and Progression Free Survival [ Time Frame: 3 months ]Description of the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase and assess ment of a possible correlation with the progression free survival.
- Impact of Choi criteria and Progression of Disease [ Time Frame: 3 months ]Correlation of Changes on the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase and progression of disease.
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): NCT02841865
|Hospital Universitario Marqués de Valdecilla|
|Santander, Cantabria, Spain|
|Hospital Universitari Vall d'Hebron|
|Hospital Universitario 12 de Octubre|
|Hospital Universitario La Paz|
|Hospital Universitario Ramón y Cajal|
|Hospital Universitario Morales Meseguer|
|Hospital Universitario Central de Asturias|
|Complejo Hospitalario de Navarra|
|Hospital Universitario Virgen del Rocio|
|Hospital Universitario Miguel Servet|
|Study Chair:||María del Pilar Solís Hernández, M.D.||Hospital Universitario Central de Asturias|
|Study Chair:||Paula Jiménez Fonseca, M.D.||Hospital Universitario Central de Asturias|
|Study Chair:||David Calvo Temprano, M.D.||Hospital Universitario Central de Asturias|