Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumor (pNET). Since the patient is eligible for treatment with either sunitinib or everolimus, it can help us identify factors that may help future patients benefit from these two therapies.
The investigators routinely monitor the progress of the treatment with magnetic resonance imaging (MRI) scans to measure how pNET tumors change in size over time. MRI can also measure how water moves within tumors, which is another way to measure how tumors respond to treatment. In this study, the investigators will look at the MRI characteristics of tumors in the liver as the patient undergoes treatment, to help us identify changes on MRI that may best predict a benefit to sunitinib or everolimus treatment.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study to Identify Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors|
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
- best response [ Time Frame: 5 years ] [ Designated as safety issue: No ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
pancreatic net pt treated with sunitinib or everolimus
A total of 20 patients with well differentiated pancreatic NET who have known liver metastases and who are planned to initiate therapy with either sunitinib or everolimus will be recruited for this study. We plan to recruit approximately 10 patients for each therapy. Evidence of metastatic disease will be determined at the discretion of the oncologist based on available imaging, surgical and pathologic evidence.
Patients will be treated with sunitinib or everolimus according to standard of care. All patients will undergo routine follow-up MRI at approximately three months intervals. ADC of liver metastases at baseline will be compared to ADC at each follow-up MRI. In addition, a research MRI will be obtained at 2 weeks following initiation of treatment, when patients are scheduled for a clinical follow-up with their oncologists. The research MRI will be otherwise identical to the clinical MRI, which include DWI sequences. The rationale for these studies is to determine if DWI can detect changes in tumor cellularity by measuring water diffusion and serve as an early predictor for response to drug therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603004
|Contact: Kinh Gian Do, M.D., Ph.D.||212-639-8591|
|Contact: Diane Reidy-Lagunes, MD||646-888-4185|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Kinh Gian Do, MD, PhD 212-639-8591|
|Contact: Diane Reidy-Lagunes, MD 646-888-4185|
|Principal Investigator: Kinh Gian Do, MD, PhD|
|Principal Investigator:||Kinh Gian Do, M.D., Ph.D.||Memorial Sloan-Kettering Cancer Center|