- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423734
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases
Time Frame: 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.
|
2 years
|
evaluate the reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Kinh Gian Do, MD,PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastro-enteropancreatic Neuroendocrine Tumor
-
David BushnellNational Cancer Institute (NCI); National Institutes of Health (NIH); Progenics...RecruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine TumorUnited States
-
IpsenCompletedGastro-Enteropancreatic Neuroendocrine TumorUnited States, Austria, Denmark
-
Advanced Accelerator ApplicationsActive, not recruitingGastro-enteropancreatic Neuroendocrine TumorSpain, United States, United Kingdom, France, Canada, Germany, Netherlands, Italy, Korea, Republic of
-
Camurus ABActive, not recruitingGastro-enteropancreatic Neuroendocrine TumorUnited States, Belgium, Spain, Netherlands, France, Germany, Israel, Italy, Canada, Australia, Romania, Hungary
-
TaiRx, Inc.Active, not recruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Tumor | Lung Neuroendocrine NeoplasmTaiwan
-
Hospices Civils de LyonUnknownMetastatic Cancer | Gastro-enteropancreatic Neuroendocrine Tumor | Health Care CostsFrance
-
University of Maryland, BaltimoreNovartisWithdrawnGastro-enteropancreatic Neuroendocrine Tumor
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedPancreatic Cancer | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinomas of Pancreas | Islet Cell CarcinomaUnited States
-
IpsenNot yet recruitingAcromegaly | Gastro-enteropancreatic Neuroendocrine Tumor
-
National Cancer Institute (NCI)RecruitingLocally Advanced Lung Neuroendocrine Neoplasm | Lung Neuroendocrine Neoplasm | Metastatic Lung Neuroendocrine Neoplasm | Recurrent Lung Neuroendocrine Neoplasm | Unresectable Lung Neuroendocrine Neoplasm | Advanced Lung Neuroendocrine Tumor | Functioning Lung Neuroendocrine Tumor | Lung Neuroendocrine... and other conditionsUnited States
Clinical Trials on magnetic resonance imaging (MRI)
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingProstate CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingBrain NeoplasmUnited States
-
University of MichiganPhilips Healthcare; General ElectricCompleted
-
M.D. Anderson Cancer CenterActive, not recruitingProstate Adenocarcinoma | Prostate CarcinomaUnited States
-
American College of RadiologyPennsylvania Department of HealthCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Recruiting
-
University of California, San FranciscoTerminatedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
University of CincinnatiActive, not recruitingProstate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
Abramson Cancer Center of the University of PennsylvaniaCompletedBrain TumorUnited States