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A Pilot Study to Identify Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neuroendocrine Cancer

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Trial Information

A Pilot Study to Identify Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression free survival

Outcome Description:

standard MRI sequences will be performed, according to guidelines from RECIST 1.1.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Kinh Gian Do, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-058

NCT ID:

NCT01603004

Start Date:

May 2012

Completion Date:

May 2014

Related Keywords:

  • Pancreatic Neuroendocrine Cancer
  • MRI
  • 12-058
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021