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

NCT01423734 | Completed

• 1 other identifier: 11-122
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor; Secondary Malignant Neoplasm of Liver

Keywords

ADRENAL GLAND; MRI; 11-122

Outcome Measures

Primary Outcomes (1)

• reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.

  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.

  2 years

Secondary Outcomes (2)

• evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases

  2 years

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

  2 years

Study Arms (1)

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.

Other: magnetic resonance imaging (MRI)

Interventions

magnetic resonance imaging (MRI) OTHER

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.

MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research patients will be identified by doctors from the Gastrointestinal Oncology Service.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Richard Kinh Gian Do, MD,PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: August 23, 2011
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

US (1)