Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01423734
First received: August 24, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes

August 24, 2011
May 6, 2013
August 2011
August 2014   (final data collection date for primary outcome measure)
reproducibility of diffusion weighted imaging for neuroendocrine liver metastases. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01423734 on ClinicalTrials.gov Archive Site
  • evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 fractions(D) of liver metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A similar application of the CCC will be employed to assess both intra-observer and interobserver variability separately for Pf and D as in the primary aim. The repeatability and reproducibility of the perfusion fraction and diffusion coefficient 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 reproducibility diffusion coefficients (D) of liver metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A similar application of the CCC will be employed to assess both intra-observer and interobserver variability separately for Pf and D as in the primary aim. The repeatability and reproducibility of the perfusion fraction and diffusion coefficient 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.
Not Provided
Not Provided
 
The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases
Pilot Study To Assess The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Gastro-enteropancreatic Neuroendocrine Tumor
  • Secondary Malignant Neoplasm of Liver
Other: magnetic resonance imaging (MRI)

Each patient will undergo clinical and research MRI examinations. Before any MRI examination, the patient will answer a standard radiology MR department questionnaire form, with specific questions addressing contra-indications to MRI. The questionnaire form will be reviewed by radiology personnel as per standard practice.

During the research MRI, the patient will be monitored visually and communication will be maintained between the patient and the MR technologists via a speaker system. At the termination of the study, the patient will be evaluated by the MR department radiology personnel as done routinely. Two breath hold DWI sequences will be performed for each patient. Since this is a reproducibility study, identical scan parameters will be used for the clinical and research MRI. The multiple b value DWI will be performed using the enhanced DW sequence that have been recently made available on our 3.0 Tesla MR 750 scanners at the Breast and Imaging Center.
Experimental: 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.
Intervention: Other: magnetic resonance imaging (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
August 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Richard Kinh Gian Do, MD, PhD 212-639-8591
Contact: Diane Reidy-Lagunes, MD 646-888-4185
United States
 
NCT01423734
11-122
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Richard Kinh Gian Do, MD,PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
May 2013

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