Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
Primary Purpose
Neuroendocrine Tumors
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MR scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
1.Patients with confirmed NET.
Exclusion Criteria:
- Patients younger than 18 years.
- Patients pregnancy.
- Patients with other known active malignancy.
- Patients contraindication to MRI tests or intravenous contrast agents.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neuroendocrine Tumors Patients
Arm Description
Patients with confirmed NET
Outcomes
Primary Outcome Measures
Patients who performing dynamic 68Ga-DOTATATE PET in the PET/MRI system and analyzing the effect of diffusion and perfusion over Ki values.
Secondary Outcome Measures
Full Information
NCT ID
NCT04152928
First Posted
October 29, 2019
Last Updated
November 4, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04152928
Brief Title
Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
Official Title
Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2020 (Anticipated)
Primary Completion Date
March 25, 2021 (Anticipated)
Study Completion Date
February 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neuroendocrine tumors (NET's) are characterized, among other features, by presence of high concentration of somatostatin receptors. In recent years, for purposes of Positron Emission Tomography (PET) imaging, somatostatin receptor ligands have been labelled with the positron emitting radioisotope 68Ga to form molecules that bind to these somatostatin receptors that are present in high concentration in NET's and in low concentrations, if at all, in normal tissues. In the last 10-15 years, radioactively labelled versions of these molecules have been used for both diagnostic and therapeutic purposes in the management of patients with NET's.
The main goal of this study is to assess the feasibility of performing dynamic 68Ga-DOTATATE PET in the PET/MRI system and analyzing the effect of diffusion and perfusion over Ki values.
Detailed Description
Working hypotheses
The PET/MR system will provide dynamic PET images of at least comparable quality compared to PET/CT. Dynamic PET/MR will be feasible, with the 45 minute dynamic PET acquisition occurring during the MR sequences, eliminating the need for the patient to undergo two separate lengthy studies.
Diffusion and perfusion parameters extracted from MRI sequences will provide information that improves the process of Ki evaluation.
The use of advanced statistics methodologies, such as those used in radiomics, to correlate Ki data with diffusion and perfusion data will provide a quantification tool that will improve staging, prediction and monitoring after treatment.
Parametric Patlak Ki images calculated from the dynamic series of PET images will show better contrast between tumors and normal tissue, as compared to contrast in the conventional static images obtained from the last time frame of the dynamic image series. Tumors identified on the static PET image will be visualized at least as well on Patlak Ki images, and possibly additional tumor foci may be identified. MRI should assist in confirming and interpreting such findings.
Research plan Population: 50 patients with NETs that have evidence of at least one abdominal lesion with diameter greater than 2cm. All patients will be aged 18 years or older of both sexes.
Inclusion criteria: Patients with confirmed NET. Exclusion criteria: Patients younger than 18 years; pregnancy; other known active malignancy; contraindication to MRI tests or intravenous contrast agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuroendocrine Tumors Patients
Arm Type
Experimental
Arm Description
Patients with confirmed NET
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR scan
Intervention Description
The patient will be positioned in the PET/MR with the field of view of the PET including the abdomen, and IV administration of 68Ga-DOTATATE will take place, with initiation of dynamic PET simultaneous with start of IV injection. Dynamic PET imaging will consist of 22 time frames of increasing durations (6 x 10, 3 x 20, 3 x 60, 5 x 180, and 5 x 300 s). The dynamic PET examination will be followed by a whole-body PET/MR scan ranging from the proximal femur to the base of the skull (3 min per bed position) starting at 60 min after injection. MR will be used for attenuation correction of the PET images of the abdomen/pelvis and whole-body. MR protocol will include three plane fast spin echo T2 weighted, DWI, DCE and ASL. The addition of PET/MR to the standard use of PET/CT adds no radiation exposure.
Primary Outcome Measure Information:
Title
Patients who performing dynamic 68Ga-DOTATATE PET in the PET/MRI system and analyzing the effect of diffusion and perfusion over Ki values.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Patients with confirmed NET.
Exclusion Criteria:
Patients younger than 18 years.
Patients pregnancy.
Patients with other known active malignancy.
Patients contraindication to MRI tests or intravenous contrast agents.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
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