Neuroendocrine TumorsNCT04152928
Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
A study testing PET/MR scan in people with Neuroendocrine Tumors, run by Tel-Aviv Sourasky Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- PET/MR scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2020to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients with confirmed NET.
Who cannot join
- Patients younger than 18 years.
- Patients pregnancy.
- Patients with other known active malignancy.
- Patients contraindication to MRI tests or intravenous contrast agents.
About this study
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.
Read the 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- PET/MR scan
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR scanDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuroendocrine Tumors Patients | Experimental | Patients with confirmed NET Receives: Diagnostic Test: PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who performing dynamic 68Ga-DOTATATE PET in the PET/MRI system and analyzing the effect of diffusion and perfusion over Ki values.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start25 Feb 2020 (estimated)
- Primary completion25 Mar 2021 (estimated)
- Study completion25 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152928
- Sponsor's protocol ID
- TASMC-19-ES-0582-CTIL
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
- ClinicalTrials.gov ID
- NCT04152928
- Acronym / sponsor ID
- TASMC-19-ES-0582-CTIL
- Conditions
- Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 25 Feb 2020 (estimated)
- Primary completion
- 25 Mar 2021 (estimated)
- Study completion
- 25 Feb 2022 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine Tumors Patients | Experimental | Diagnostic Test: PET/MR scanPatients with confirmed NET |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients with confirmed NET.
Key exclusion criteria (4 listed)
- Patients younger than 18 years.
- Patients pregnancy.
- Patients with other known active malignancy.
- Patients contraindication to MRI tests or intravenous contrast agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MR scanThe 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. | Diagnostic test | Neuroendocrine Tumors Patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR scan in people with Neuroendocrine Tumors, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.