Hodgkin LymphomaADAMANTIUSNCT02300402
Detection and Characterization of Residual Masses in Lymphomas
An observational study of Hodgkin Lymphoma and B-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 1 site in France.
Trial summary
The present study aims to further optimize a whole-body Diffusion-Weighted Magnetic Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body parametric image analysis algorithm, and to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hodgkin Lymphoma, B-Cell Lymphoma
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed HL, DLBCL or FL At least 18 years of age Initial presentation of bulky disease
Who may be able to join
- Newly diagnosed hodgkin's lymphoma, diffuse large B-cell lymphoma or follicular lymphoma
- Patients aged over 18
- Initial presentation of bulky disease
Who cannot join
- Patients with impaired central nervous system
- Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
- Patients who have undergone major surgery during the 28 days preceding the inclusion
- Patients with low kidney and/or liver function
- Patients with HIV +
- Patients whose life expectancy ≤ 6 months
- Patients with other medical problems or psychological susceptibles interfere with the study,
- Patients under adult supervision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automatic Detection and Characterization of Residual Masses in Patients With Lymphomas Through Fusion of Whole-Body Diffusion-Weighted MRI on 3 Tesla and 18F-Fluorodeoxyglucose PET/CT
The present study aims to further optimize a whole-body Diffusion-Weighted Magnetic Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to Fluorodeoxyglucose-PET for the management of lymphoma patients.
Read the detailed description
Imaging biomarkers are important tools for the detection and characterization of cancers as well as for monitoring the response to therapy. "Whole-body" molecular imaging, in particular using 18-Fluorodeoxyglucose-PET, has been proven useful in the evaluation and management of lymphoma patients. FDG-PET has evolved as a valuable biomarker in aggressive lymphomas, which is the current state-of-the-art imaging technique for response assessment at the end of treatment. Additionally, the prognostic value of "interim" (during treatment) or early PET has been well established in Hodgkin lymphoma and diffuse large B-cell lymphoma, which together account for more than 50% of all lymphomas. Worldwide clinical trials are ongoing to evaluate risk-adapted individualized treatment strategy based on interim PET results. Therefore, uniform and evidence-based guidelines for the interpretation are warranted. International Workshop on Interim PET in Lymphoma recently proposed a 5-point score method and so far the results of validation studies are promising.
However, one could speculate that the risk of false-positive studies due to a non-specific inflammatory effect will be greater when patients receiving more toxic regimens and the usefulness of imaging biomarkers would vary for different lymphoma subtypes. Meanwhile, thanks to rapid technical development, whole-body functional magnetic resonance imaging (MRI) in particular diffusion-weighted MRI (DWI) reflecting cell density is now feasible in the clinical setting. Quantitative parameters derived from DWI reflecting cell density may provide complementary information to current state-of-the-art FDG-PET imaging reflecting quantitatively glucose metabolism and prove to be helpful in patient management.
Pilot studies have shown the potential of whole-body DWI in lymphomas for staging and response assessment on 1.5 Tesla MR system but larger-scaled prospective studies are required before this new imaging-based biomarker can ever be validated for routine clinical use. Besides, technical challenges remain especially when encountering higher-field clinical MR systems. Finally, a vast amount of information generated from whole-body parametric imaging data will require development of automated image analysis software, which may help in establishing a multi-parametric approach in characterizing residual lymphoma masses.
Therefore, the present study aims to further optimize a whole-body DWI protocol on 3 Tesla MR and/or new system combining 3Tesla MR and PET, to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to FDG-PET for the management of lymphoma patients.
- Conditions
- Hodgkin Lymphoma, B-Cell Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
apparent diffusion coefficient changes of post-treatment residual lymphoma masses and whether this MR-derived parameter helps in characterizing its viability in addition to PET
Measured: Baseline
correlation between standardized uptake value and apparent diffusion coefficient changes; correlation with post-treatment histopathological findings if tissue proof
Measured: Baseline, 6 weeks, between 18 and 24 weeks
correlation between the PET and MR-derived functional parameters with clinical outcome (end-treatment response and survival)
Measured: Between 18 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Rahmouni, Prof., Principal investigator, CHU Henri MondorCorinne Haioun, Prof., Principal investigator, Lymphoma Study AssociationEmmanuel Itti, Prof., Principal investigator, CHU Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300402
- Sponsor's protocol ID
- ADAMANTIUS
- Acronym
- ADAMANTIUS
- Status last verified
- Mar 2023
- First submitted
- 11 Sep 2014
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Detection and Characterization of Residual Masses in Patients With Lymphomas Through Fusion of Whole-Body Diffusion-Weighted MRI on 3 Tesla and 18F-Fluorodeoxyglucose PET/CT
- ClinicalTrials.gov ID
- NCT02300402
- Acronym / sponsor ID
- ADAMANTIUS / ADAMANTIUS
- Conditions
- Hodgkin Lymphoma, B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 25 Nov 2014 (estimated)
- 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 present study aims to further optimize a whole-body Diffusion-Weighted Magnetic Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to Fluorodeoxyglucose-PET for the management of lymphoma patients.
Detailed description
Imaging biomarkers are important tools for the detection and characterization of cancers as well as for monitoring the response to therapy. "Whole-body" molecular imaging, in particular using 18-Fluorodeoxyglucose-PET, has been proven useful in the evaluation and management of lymphoma patients. FDG-PET has evolved as a valuable biomarker in aggressive lymphomas, which is the current state-of-the-art imaging technique for response assessment at the end of treatment. Additionally, the prognostic value of "interim" (during treatment) or early PET has been well established in Hodgkin lymphoma and diffuse large B-cell lymphoma, which together account for more than 50% of all lymphomas. Worldwide clinical trials are ongoing to evaluate risk-adapted individualized treatment strategy based on interim PET results. Therefore, uniform and evidence-based guidelines for the interpretation are warranted. International Workshop on Interim PET in Lymphoma recently proposed a 5-point score method and so far the results of validation studies are promising.
However, one could speculate that the risk of false-positive studies due to a non-specific inflammatory effect will be greater when patients receiving more toxic regimens and the usefulness of imaging biomarkers would vary for different lymphoma subtypes. Meanwhile, thanks to rapid technical development, whole-body functional magnetic resonance imaging (MRI) in particular diffusion-weighted MRI (DWI) reflecting cell density is now feasible in the clinical setting. Quantitative parameters derived from DWI reflecting cell density may provide complementary information to current state-of-the-art FDG-PET imaging reflecting quantitatively glucose metabolism and prove to be helpful in patient management.
Pilot studies have shown the potential of whole-body DWI in lymphomas for staging and response assessment on 1.5 Tesla MR system but larger-scaled prospective studies are required before this new imaging-based biomarker can ever be validated for routine clinical use. Besides, technical challenges remain especially when encountering higher-field clinical MR systems. Finally, a vast amount of information generated from whole-body parametric imaging data will require development of automated image analysis software, which may help in establishing a multi-parametric approach in characterizing residual lymphoma masses.
Therefore, the present study aims to further optimize a whole-body DWI protocol on 3 Tesla MR and/or new system combining 3Tesla MR and PET, to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to FDG-PET for the management of lymphoma patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed HL, DLBCL or FL At least 18 years of age Initial presentation of bulky disease
Key inclusion criteria (3 listed)
- Newly diagnosed hodgkin's lymphoma, diffuse large B-cell lymphoma or follicular lymphoma
- Patients aged over 18
- Initial presentation of bulky disease
Key exclusion criteria (8 listed)
- Patients with impaired central nervous system
- Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
- Patients who have undergone major surgery during the 28 days preceding the inclusion
- Patients with low kidney and/or liver function
- Patients with HIV +
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
apparent diffusion coefficient changes of post-treatment residual lymphoma masses and whether this MR-derived parameter helps in characterizing its viability in addition to PET
Time frame: Baseline
correlation between standardized uptake value and apparent diffusion coefficient changes; correlation with post-treatment histopathological findings if tissue proof
Time frame: Baseline, 6 weeks, between 18 and 24 weeks
correlation between the PET and MR-derived functional parameters with clinical outcome (end-treatment response and survival)
Time frame: Between 18 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Alain Rahmouni, Prof. principal investigator
CHU Henri Mondor
Corinne Haioun, Prof. principal investigator
Lymphoma Study Association
Emmanuel Itti, Prof. principal investigator
CHU Henri Mondor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma and B-Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 1 site in France.
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 8 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: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
apparent diffusion coefficient changes of post-treatment residual lymphoma masses and whether this MR-derived parameter helps in characterizing its viability in addition to PET (time frame: Baseline). The study lists 3 primary outcomes in all. 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 20 Mar 2023.