LymphomaNCT03969381
Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Patients With Lymphoma
An observational study of Lymphoma, run by Assiut University.
Trial summary
The goal of this study is to determine the feasibility of the diffusion weighted Magnetic Resonance Imaging in the evaluation of the treatment response in patients with malignant lymphoma. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- diffusion weighted magnetic resonance image in lymphoma
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 Jan 2022
- Phase
- Observational
- 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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed as malignant lymphoma
Who may be able to join
- patients clinically diagnosed as lymphoma patient can tolerate the magnetic resonance examination.
Who cannot join
- presence of paramagnetic substance as peace maker or cochlear implants and claustrophobia.
Trial locations and contacts
No sites are listed yet.
Khodary Omran, lecturer contact
About this study
Official title: Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Evaluation of Patients With Malignant Lymphoma: Comparison With 2-deoxy-2-fluoro-D-glucose-positron Emission Tomography/Computed Tomography
- The goal of this study is to determine the feasibility of the diffusion weighted Magnetic Resonance Imaging in the evaluation of the treatment response in patients with malignant lymphoma.
- The investigator's objective is to compare the changes of mean Apparent Diffusion Coefficient value of the tumor with the changes of maximum Standardized Uptake Value of the tumor in positron Emission Tomography Computed Tomography in both pre and post therapy status .
Read the detailed description
Lymphomas are the malignant tumors of lymph nodes and considered as one of the most common primary hematopoietic malignancy. Multi slice computed tomography is the most readily available and most commonly used tool for staging lymphoma. But it has multiple limitations in diagnosis of lymphoma as the recognition of lymph node involvement is based only on the size of the lymph node without any metabolic information .
The tumors rely on glucose as their substrate for energy production and replication, this metabolic information can be obtained from the 2-deoxy-2-fluoro-D-glucose Among the positron Emission Tomography Computed Tomography parameters, standardized uptake value is currently the most commonly used semi-quantitative index of 2-deoxy-2-fluoro-D-glucose metabolic rate. standardized uptake value reflects tumor glucose metabolism, and is commonly represented by the maximum standardized uptake value .2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography has been shown to be more accurate for the evaluation of the extent of disease and treatment response by providing these metabolic information in patients with malignant lymphoma .
2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography , with the advantage of being able to perform whole-body detection of malignant lesions, is considered to be the current standard of practice for the management of lymphomas; however, positron Emission Tomography Computed Tomography is expensive, time-consuming, involves exposure to ionizing radiation and is not widely available because it requires large and expensive equipment . In contrast, Magnetic Resonance Imaging provides excellent tissue contrast, high spatial resolution, detailed morphological information without the use of ionizing radiation . Diffusion-weighted Magnetic Resonance Imaging is a noninvasive technique allows visualization of diffusion properties of water molecules in biologic tissues. .
A supplemental tool in Diffusion-weighted imaging is the apparent diffusion coefficient map , acquired by post-processing of the obtained Diffusion-weighted images . apparent diffusion coefficient allows for quantitative definition of diffusion parameters (in mm2/sec) . Diffusion-weighted images with apparent diffusion coefficient mapping could provide useful functional information regarding the characterization of lymphomas .Because of their high cellularity and high nuclear-to-cytoplasm ratio .
- Conditions
- Lymphoma
- Being tested
- diffusion weighted magnetic resonance image in lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion weighted magnetic resonance image in lymphomaRadiation
compare between result of positron emission tomography /computed tomography and diffusion weighted imaging in followup of lymphoma
| Study group | Role | What they receive |
|---|---|---|
| 1 lymphoma patients | pre therapy and post therapy of lymphoma patients Receives: Radiation: diffusion weighted magnetic resonance image in lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
role of diffusion weighted imaging in followup of lymphoma
- measures mean Apparent diffusion coefficient value in pre and post therapy status in patients with lymphoma with cut off value 1 .
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Sep 2019 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jan 2022 (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 Assiut UniversityThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ali Gamal, Assiut University
- Investigators
- sara, Msc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969381
- Sponsor's protocol ID
- lymphoma
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Evaluation of Patients With Malignant Lymphoma: Comparison With 2-deoxy-2-fluoro-D-glucose-positron Emission Tomography/Computed Tomography
- ClinicalTrials.gov ID
- NCT03969381
- Acronym / sponsor ID
- lymphoma
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 31 May 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.
- The goal of this study is to determine the feasibility of the diffusion weighted Magnetic Resonance Imaging in the evaluation of the treatment response in patients with malignant lymphoma.
- The investigator's objective is to compare the changes of mean Apparent Diffusion Coefficient value of the tumor with the changes of maximum Standardized Uptake Value of the tumor in positron Emission Tomography Computed Tomography in both pre and post therapy status .
Detailed description
Lymphomas are the malignant tumors of lymph nodes and considered as one of the most common primary hematopoietic malignancy. Multi slice computed tomography is the most readily available and most commonly used tool for staging lymphoma. But it has multiple limitations in diagnosis of lymphoma as the recognition of lymph node involvement is based only on the size of the lymph node without any metabolic information .
The tumors rely on glucose as their substrate for energy production and replication, this metabolic information can be obtained from the 2-deoxy-2-fluoro-D-glucose Among the positron Emission Tomography Computed Tomography parameters, standardized uptake value is currently the most commonly used semi-quantitative index of 2-deoxy-2-fluoro-D-glucose metabolic rate. standardized uptake value reflects tumor glucose metabolism, and is commonly represented by the maximum standardized uptake value .2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography has been shown to be more accurate for the evaluation of the extent of disease and treatment response by providing these metabolic information in patients with malignant lymphoma .
2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography , with the advantage of being able to perform whole-body detection of malignant lesions, is considered to be the current standard of practice for the management of lymphomas; however, positron Emission Tomography Computed Tomography is expensive, time-consuming, involves exposure to ionizing radiation and is not widely available because it requires large and expensive equipment . In contrast, Magnetic Resonance Imaging provides excellent tissue contrast, high spatial resolution, detailed morphological information without the use of ionizing radiation . Diffusion-weighted Magnetic Resonance Imaging is a noninvasive technique allows visualization of diffusion properties of water molecules in biologic tissues. .
A supplemental tool in Diffusion-weighted imaging is the apparent diffusion coefficient map , acquired by post-processing of the obtained Diffusion-weighted images . apparent diffusion coefficient allows for quantitative definition of diffusion parameters (in mm2/sec) . Diffusion-weighted images with apparent diffusion coefficient mapping could provide useful functional information regarding the characterization of lymphomas .Because of their high cellularity and high nuclear-to-cytoplasm ratio .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 lymphoma patients | – | Radiation: diffusion weighted magnetic resonance image in lymphomapre therapy and post therapy of lymphoma patients |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed as malignant lymphoma
Key inclusion criteria (1 listed)
- patients clinically diagnosed as lymphoma patient can tolerate the magnetic resonance examination.
Key exclusion criteria (1 listed)
- presence of paramagnetic substance as peace maker or cochlear implants and claustrophobia.
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 |
|---|---|---|
| diffusion weighted magnetic resonance image in lymphomacompare between result of positron emission tomography /computed tomography and diffusion weighted imaging in followup of lymphoma | Radiation | 1 lymphoma patients |
Primary outcome
role of diffusion weighted imaging in followup of lymphoma
Time frame: 5 minutes
• measures mean Apparent diffusion coefficient value in pre and post therapy status in patients with lymphoma with cut off value 1 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Imaging for Staging and Response Assessment in LymphomaLink provided by the sponsor.
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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.
Khodary Omran, lecturer contact
sara, Msc principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Assiut University.
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 1 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 31 May 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?
Contact Abouzeid Hazem, professor (01005075888, sarad423@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of diffusion weighted imaging in followup of lymphoma (time frame: 5 minutes). 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 31 May 2019.