Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01603004
First received: May 16, 2012
Last updated: May 23, 2014
Last verified: May 2014

May 16, 2012
May 23, 2014
May 2012
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01603004 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
A Pilot Study to Identify 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Potential research patients will be identified by doctors from the Gastrointestinal Oncology Service in the Department of Medicine.

Pancreatic Neuroendocrine Cancer
Other: MRI
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.
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.
Intervention: Other: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histopathologic evidence of well differentiated pancreatic neuroendocrine tumor
  • Evidence of metastatic disease of at least 2.0 cm in the liver by prior MRI or CT imaging. Both patients with synchronous disease and those with prior resected primary cancers will be eligible.
  • Patient ≥18 years of age on the day of signing informed consent.
  • Planned initiation of active therapy with either everolimus or sunitinib. Patients can be included in this study, regardless of prior therapy, but cannot undergo concurrent therapy, such as hepatic artery embolization
  • Available archival tissue with adequate FFPE tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate DNA preparation. For larger biopsies and any resections, 5 slides are sufficient for DNA extraction).

Exclusion Criteria:

  • Any contraindication to MRI based on departmental MR questionnaire
  • Inability to cooperate for an MR exam
  • Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy or one that would not interfere with the MRI results are allowed.
  • Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
Both
18 Years and older
No
Contact: Kinh Gian Do, M.D., Ph.D. 212-639-8591
Contact: Diane Reidy-Lagunes, MD 646-888-4185
United States
 
NCT01603004
12-058
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Kinh Gian Do, M.D., Ph.D. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP