Clinical Trial: Evaluation of Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria

Brief Summary:

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.


Detailed Summary:
Sponsor: Grupo Espanol de Tumores Neuroendocrinos

Current Primary Outcome:

  • Response to treatment [ Time Frame: 3 months ]
    According Choi Criteria
  • Response to treatment [ Time Frame: 3 months ]
    According RECIST Criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival on partial response [ Time Frame: 3 months ]
  • Progression Free Survival on Stable Disease [ Time Frame: 3 months ]
  • 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.


Original Secondary Outcome: Same as current

Information By: Grupo Espanol de Tumores Neuroendocrinos

Dates:
Date Received: July 20, 2016
Date Started: August 2016
Date Completion: November 2017
Last Updated: March 28, 2017
Last Verified: March 2017