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Clinical Trials/NCT01423734
NCT01423734
Completed
Not Applicable

Pilot Study To Assess The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

Memorial Sloan Kettering Cancer Center1 site in 1 country20 target enrollmentAugust 23, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastro-enteropancreatic Neuroendocrine Tumor
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
20
Locations
1
Primary Endpoint
reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with the same treatment. On the other hand, growing tumors in a patient can bring about a change in therapy. Unfortunately, it often takes three to six months, or even longer before the investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools that can look at how tumors respond early on during treatment. This study will help us decide if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful imaging tool.

Registry
clinicaltrials.gov
Start Date
August 23, 2011
End Date
January 19, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.

Time Frame: 2 years

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.

Secondary Outcomes

  • evaluate the reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases(2 years)
  • evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases(2 years)

Study Sites (1)

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