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Developing a Method Using PET-MR to Improve Staging and Monitoring of Neuroendocrine Tumor

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ClinicalTrials.gov Identifier: NCT04154241
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE October 29, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date November 6, 2019
Estimated Study Start Date  ICMJE March 10, 2020
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
Patients who preformed PET/MR. [ Time Frame: 1 year ]
The investigators develop new methods for the characterization and monitoring of NETs using the latest state of the art PET-MR technology combined with big data analysis methods in order to obtain a more accurate, specific and sensitive biomarker.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing a Method Using PET-MR to Improve Staging and Monitoring of Neuroendocrine Tumor
Official Title  ICMJE Developing a Method Using PET-MR to Improve Staging and Monitoring of Neuroendocrine Tumor
Brief Summary euroendocrine tumors (NETs) are neoplasms that originate from diffuse neuroendocrine system which consist about 17 types of different neuroendocrine cells. These cells combine properties of nerve cells with properties of endocrine cells, that is they receive neuronal signal and produce hormones.The most common locations for NETs are the lungs and organs of the gastroenteropancreatic (GEP) system, however they can be found in any other organ in the body . Clinically, functional NET cells secrete hormones which cause symptoms such as diarrhea or flushing, however non-functional NET cells also exist posing a challenge in the identification and diagnosis of the disease . Besides surgery to remove the tumor, there are numerous of treatment options for systemic handling of the NETs. These treatments include: somatostatin analogues, interferon, chemotherapy, transarterial (chemo) embolisation, radiofrequency ablation, sunitinib, everolimus and radionuclide targeted therapy. The choice of treatment depends on the correct characterization of the NET, primary tumor location, tumor subtype, grade and stage of the disease . Biomarkers for NETs serve a critical role in the diagnosis stage, where it is highly important to identify the NET type and precise location. Furthermore, selecting the correct biomarkers for monitoring the disease is important to predict response for treatment and allow the choice of the right treatment from the large variety of treatment options. NET biomarkers include circulating biomarkers such as Chromogranin A, Ki67, Neuron Specific Enolase (NSE), 5 hydroxyindoleacetic acid (5HIAA) and many others found in blood samples, or in the tumor tissue . Beside the circulating biomarkers, imaging biomarkers plays a central role in diagnosis, staging, treatment selection and follow-up of NETs . Current imaging tools are morphological modalities such as CT, MRI and Ultrasound and molecular imaging. Several types of molecular imaging techniques are performed to characterize NETs: single photon emission computed tomography (SPECT) with 111In-pentetreotide, largely superseded now by positron emission tomography (PET) with 68Ga-labeled somatostatin analogs, is used to identify the somatostatin receptor status.
Detailed Description

18F-DOPA and 11C-5-HTP are used to evaluate neuroendocrine metabolism . 18-fluoro-deoxy-glucose (FDG) PET is usually a poor indication for NETs since these neoplasms tend to be metabolic inactive, and thus FDG-PET is only used for high grade more aggressive NETs . Only a combination of several biomarkers together can lead to NET description that allows treatment selection and to some extent prediction of treatment success.

In this study the investigators wish to take advantage of the new hybrid PET-MR and use it to find new methods to characterize NETs. Only very few PET-MR studies have been performed with correlation to NETs and they showed the potential of this tool for tumor characterization .

The investigators plan to integrate PET-MR with big data analysis methods to obtain an improved tool for staging, characterization and monitoring NETs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Diagnostic Test: PET/MR scan

The PET will be performed with (68Ga)-labeled somatostatin analogue since it was proven to be superior to other NET PET tracers in terms of lesion detection and sensitivity [11] [12]. The 3 tesla magnet of the MRI should allow acquisition of several contrasts within a reasonable time frame. The protocol will include T1 and T2-weighted images, diffusion-weighted images with multiple b values and apparent diffusion coefficient (ADC) maps.

All images will be analyzed with big data tools such as radiomics and texture analysis in order to integrate all image parameters and different contrasts into individual tumor status. Then, accuracy, sensitivity and specificity will be evaluated by correlation of this data collection and analysis method with histological biomarkers (for example, Ki67 level) and treatment results.

Study Arms  ICMJE Experimental: neuroendocrine tumor Patients
A cohort of patients that were diagnosed with NET using biopsy.
Intervention: Diagnostic Test: PET/MR scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 10, 2022
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A cohort of patients that were diagnosed with NET using biopsy.

Exclusion Criteria:

  1. Age <18.
  2. Pregnant or breast feeding patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154241
Other Study ID Numbers  ICMJE TASMC-19-ES-0583-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date November 2019

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