LymphomaNCT04154228
Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
A study testing PET/MR scan in people with Lymphoma and Non Hodgkin Lymphoma, run by Tel-Aviv Sourasky Medical Center.
Trial summary
18F-FDG PET/MR imaging protocol integrating advanced MR vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
- 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2019to 10 Dec 2021
- 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
- patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
- Patients aged 18 years or older of both sexes.
- Patients treated at Tel-Aviv Sourasky Medical center.
Who cannot join
- pregnancy,
- contraindication to MRI or to intravenous gadolinium injection.
About this study
18F-FDG PET/MR imaging protocol integrating advanced MR vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. The aim of this prospective study is to develop an automatic artificial intelligence-based tool for the assessment of early response to treatment and evaluation of residual masses in patients with lymphoma. Specific objectives are:
- To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.
- To optimize PET/MR imaging protocol for lymphoma assessment.
- To develop an automated tool for staging patients with lymphoma.
- To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.
- To develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.
- Conditions
- Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
- Being tested
- PET/MR scan
- Keywords
- Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR scanDiagnostic test
Patients will undergo 18F-FDG PET/CT scans before therapy initiation, interim after 2/3 treatment cycles and end of treatment after therapy completion, as part of their routine evaluation, as well as additional follow-up scans, as clinically indicated and requested by referring physicians. Given signed written informed-consent forms, patients will undergo at each time point, immediately after completion of PET/CT, a PET/MR scan, following the same single injection of 18F-FDG. Standard preparation and acquisition protocols for FDG PET imaging will be employed.
PET/MR imaging will include conventional sequences as T1, T2, diffusion weighted imaging, and advanced vascular imaging (DCE-MRI).
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma Patients | Experimental | Not described Receives: Diagnostic Test: PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT, and the investigators optimize PET/MRI imaging protocol, and to develop an automated artificial intelligence-based tool for assessment of early response to treatment in patients with lymphoma.
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 start10 Dec 2019 (estimated)
- Primary completion10 Jan 2020 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 100 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
- NCT04154228
- Sponsor's protocol ID
- TASMC-19-ES-0556-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
- Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
- ClinicalTrials.gov ID
- NCT04154228
- Acronym / sponsor ID
- TASMC-19-ES-0556-CTIL
- Conditions
- Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
- Keywords
- Lymphoma, Non Hodgkin Lymphoma, Follicular Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 10 Dec 2019 (estimated)
- Primary completion
- 10 Jan 2020 (estimated)
- Study completion
- 10 Dec 2021 (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.
18F-FDG PET/MR imaging protocol integrating advanced MR vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. The aim of this prospective study is to develop an automatic artificial intelligence-based tool for the assessment of early response to treatment and evaluation of residual masses in patients with lymphoma. Specific objectives are:
- To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.
- To optimize PET/MR imaging protocol for lymphoma assessment.
- To develop an automated tool for staging patients with lymphoma.
- To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.
- To develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoma Patients | Experimental | Diagnostic Test: PET/MR scan |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
- Patients aged 18 years or older of both sexes.
- Patients treated at Tel-Aviv Sourasky Medical center.
Key exclusion criteria (2 listed)
- pregnancy,
- contraindication to MRI or to intravenous gadolinium injection.
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 scanPatients will undergo 18F-FDG PET/CT scans before therapy initiation, interim after 2/3 treatment cycles and end of treatment after therapy completion, as part of their routine evaluation, as well as additional follow-up scans, as clinically indicated and requested by referring physicians. Given signed written informed-consent forms, patients will undergo at each time point, immediately after completion of PET/CT, a PET/MR scan, following the same single injection of 18F-FDG. Standard preparation and acquisition protocols for FDG PET imaging will be employed. PET/MR imaging will include conventional sequences as T1, T2, diffusion weighted imaging, and advanced vascular imaging (DCE-MRI). | Diagnostic test | Lymphoma Patients |
Primary outcome
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT
Time frame: 1 year
Patients that preform 18F-FDG PET/MRI and the routinely PET/CT, and the investigators optimize PET/MRI imaging protocol, and to develop an automated artificial intelligence-based tool for assessment of early response to treatment in patients with lymphoma.
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 Lymphoma and Non Hodgkin Lymphoma, 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 3 inclusion and 2 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 that preform 18F-FDG PET/MRI and the routinely PET/CT (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.