Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2022
CompletedNovember 6, 2019
November 1, 2019
1.1 years
October 29, 2019
November 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Patients who performing dynamic 68Ga-DOTATATE PET in the PET/MRI system and analyzing the effect of diffusion and perfusion over Ki values.
1 year
Study Arms (1)
Neuroendocrine Tumors Patients
EXPERIMENTALPatients with confirmed NET
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with confirmed NET.
You may not qualify if:
- Patients younger than 18 years.
- Patients pregnancy.
- Patients with other known active malignancy.
- Patients contraindication to MRI tests or intravenous contrast agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 6, 2019
Study Start
February 25, 2020
Primary Completion
March 25, 2021
Study Completion
February 25, 2022
Last Updated
November 6, 2019
Record last verified: 2019-11