The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

Completed

• Conditions: Gastro-enteropancreatic Neuroendocrine Tumor; Secondary Malignant Neoplasm of Liver
• Interventions: Other: magnetic resonance imaging (MRI)

• Registration Number: NCT01423734
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-23
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Status Verified: 2023-01
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI	magnetic resonance imaging (MRI)	Patients will be consented for a second MRI without additional intravenous contrast, referred to from now on as 'research MRI', to be performed later on the same day as their clinical liver MR examination, on one of two 3.0 Tesla MR 750 GE scanners at the Breast and Imaging Center. The research MRI will consist only of the localizer and diffusion weighted imaging (DWI) sequences, with acquisition parameters identical to our clinical MRI. The reproducibility of DWI is best assessed in separate MR imaging sessions, although the examinations can be performed the same day.

Primary Outcome Measures

Name	Time	Method
reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.	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 Outcome Measures

Name	Time	Method
evaluate the reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases	2 years	A similar application of the CCC will be employed to assess both intra-observer and interobserver variability separately for ADC high as in the primary aim. The repeatability and reproducibility of the ADC high will then be compared to the most repeatable and reproducible ADC measures identified in Aim 1 by ranking the CCC values and selecting the measure with the highest value.
evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases	2 years	A similar application of the CCC will be employed to assess both intra-observer and interobserver variability separately for ADC high as in the primary aim. The repeatability and reproducibility of the ADC high will then be compared to the most repeatable and reproducible ADC measures identified in Aim 1 by ranking the CCC values and selecting the measure with the highest value.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States