Trial Information
Pilot Study To Assess The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases
Inclusion Criteria:
- Histopathologic evidence of well differentiated neuroendocrine tumor of
gastroenteropancreatic origin
- Evidence of metastatic disease of at least 2.0 cm in the liver by MRI or CT imaging.
- Patient ≥18 years of age on the day of signing informed consent.
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 is 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:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.
Outcome Description:
The investigators will calculate an ADC value for each metastasis that was chosen through consensus by the two participating radiologists. ADC is a voxel-level measurement so summary measures will be employed in order to get a single measurement for the ROI of each metastasis under study. For both the clinical and research MRI, the investigators will take the voxel-level data and calculate the mean, median, and minimum ADC within each ROI.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Richard Kinh Gian Do, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
11-122
NCT ID:
NCT01423734
Start Date:
August 2011
Completion Date:
August 2014
Related Keywords:
- Gastro-enteropancreatic Neuroendocrine Tumor
- Secondary Malignant Neoplasm of Liver
- ADRENAL GLAND
- MRI
- 11-122
- Neoplasms
- Liver Neoplasms
- Neoplasm Metastasis
- Neuroendocrine Tumors
- Neoplasms, Second Primary
- Intestinal Neoplasms
- Pancreatic Neoplasms
- Stomach Neoplasms
Name | Location |
Memorial Sloan Kettering Cancer Center |
New York, New York 10021 |