Diffuse Large B-cell-lymphomaNCT03042247
Prospective Comparison Between FDG-PET/MR and FDG-PET/CT in Classical Hodgkin Lymphoma and DLBC Non-Hodgkin Lymphoma
An observational study of Diffuse Large B-cell-lymphoma and Classical Hodgkin Lymphoma, run by Marco Picardi at 2 sites in Italy.
Trial summary
According to the most recent guidelines, total-body imaging techniques are an indispensable element in the staging and post-treatment re-evaluation in patients with lymphoma. Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the gold-standard for the assessment of the disease in these… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diffuse Large B-cell-lymphoma, Classical Hodgkin Lymphoma
- What is being tested?
- FDG PET/TC and FDG PET/MRI
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 24 Jan 2017to 1 Feb 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients (>18 yrs) with histological diagnosis of classical Hodgkin lymphoma and non-Hodgkin diffuse large B-cell lymphoma.
Who may be able to join
- Histologically confirmed diagnosis of classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma;
- Age ≥18 years;
- The need of anti-neoplastic treatment;
- Written informed consent;
Who cannot join
- Carriers of cardiac pacemakers;
- Carriers of metal mesh implants, tissue expanders (breast);
- Holders of metal implants, cochlear implants and stapedial prostheses, plates or screws, wires, nails, spinal-column distractors, ferromagnetic vascular clips, mechanical heart valves, Swan-Ganz catheter, endocorporal electrodes, neurostimulators, vascular filters, stents and metal spirals that they do not know the characteristics (the manufacturer, type and date of implant) and/or secure magnetic compatibility;
- Holders of metal fragments in the eye, visceral or intracranial;
- Tattoo holders executed by less than 6 months;
- Claustrophobic patients;
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- Pregnant patients;
- Patients with uncontrolled diabetes mellitus;
- Patients who do not provide written informed consent to the study.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Prof Marco Picardi - Hematology - AOU FEDERICO II
Naples, 80131
Roberta Della Pepa, MD, +390817462037, roberta.dellapepa@unina.it
- Recruiting
Prof Marco Picardi
Naples, 80131
Roberta Della Pepa, MD, +390817462037, roberta.dellapepa@unina.it
About this study
Official title: Prospective Comparison Between FDG-positron Emission Tomography (FDG-PET)/Magnetic Resonance and FDG-PET/Computed Tomography for Staging, Interim Assessment and Restaging in Classical Hodgkin Lymhoma and DLBC Non-Hodgkin Lymphoma
According to the most recent guidelines, total-body imaging techniques are an indispensable element in the staging and post-treatment re-evaluation in patients with lymphoma. Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the gold-standard for the assessment of the disease in these patients. The use of alternative methods, without radiation, such as whole-body magnetic resonance imaging (MRI), could be a valid alternative; this would result an advantage, considering the young age of the majority of patients at diagnosis and the need to undergo to serial assessments. The recent introduction of combined PET total body MRI (PET/MRI) offers the possibility to integrate morphological information with the high resolution of MRI with the metabolic activity of PET, through the uptake of FDG, for a more accurate definition of the extent of disease in patients with lymphoma.
Read the detailed description
All patients diagnosed with classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma that meet the inclusion criteria will be enrolled in the study. They will undergo an FDG-PET/CT for defining the staging and the therapeutic strategy. PET/MRI scans will be performed immediately upon completion of the PET/contrast-enhanced CT study and FDG tracer will be injected before the PET/CT exam and PET/MRI acquisitions will be practiced using the residual activity of the tracer. All patients will have to provide their informed consent in order to participate in the study.
The combined assessment FDG-PET/CT and FDG-PET/MRI will be performed at diagnosis for staging, at the interim evaluation for early assessment of treatment response after 2 cycles of chemotherapy and finally the post-chemotherapy re-staging. The enrollment period is 24 months for a total of 60 patients with Hodgkin lymphoma and 60 with DLBC non Hodgkin lymphoma.
Patients enrolled in the study will be followed for the diagnostic/therapeutic program at the Hematology Department of Federico II University of Naples, while the FDG-PET/CT and FDG-PET/MRI examinations will be carried out at the IRCSS SDN of Naples. The acquired images will be evaluated by a panel of experienced radiologists and nuclear physicians at the IRCSS SDN Naples.
The results obtained from the examination MRI will not modify in any way the clinical therapeutic choices in the planned chemotherapy for the patient, who will not receive additional radiations. This prospective pilot study will be conducted after approval by the Ethics Committee; each patient will sign an appropriate informed consent.
- Being tested
- FDG PET/TC and FDG PET/MRI
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/TC and FDG PET/MRIDiagnostic test
Combined assessment with FDG PET/TC and PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Hodgkin lymphoma patients | Hodgkin lymphoma patients with confirmed histological diagnosis Receives: Diagnostic Test: FDG PET/TC and FDG PET/MRI | |
| DLBC non Hodgkin lymphoma patients | DLBC non Hodgkin lymphoma patients with confirmed histological diagnosis Receives: Diagnostic Test: FDG PET/TC and FDG PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation
Evaluate the diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation (early treatment response after 2 cycles of chemotherapy and final assessment) in patients with classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma, as compared to conventional assessment by FDG PET/ contrast-enhanced CT
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 posted3 Feb 2017 (estimated)
- Study start24 Jan 2017
- Primary completion10 Jun 2020
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell-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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Picardi
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor-investigator, Marco Picardi, Federico II University
- Investigators
- Fabrizio Pane, Prof, Principal investigator, Hematology - AOU Federico II - Naples - ItalyMarco Picardi, Prof, Study director, Hematology - AOU Federico II - Naples - ItalyAndrea Soricelli, Prof, Study chair, IRCSS SDN - Naples - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042247
- Sponsor's protocol ID
- FDGMR-LIN
- Status last verified
- Jun 2020
- First submitted
- 24 Jan 2017
- Last updated
- 12 Jun 2020
- 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 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between FDG-positron Emission Tomography (FDG-PET)/Magnetic Resonance and FDG-PET/Computed Tomography for Staging, Interim Assessment and Restaging in Classical Hodgkin Lymhoma and DLBC Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03042247
- Acronym / sponsor ID
- FDGMR-LIN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marco PicardiUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 3 Feb 2017 (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.
According to the most recent guidelines, total-body imaging techniques are an indispensable element in the staging and post-treatment re-evaluation in patients with lymphoma. Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the gold-standard for the assessment of the disease in these patients. The use of alternative methods, without radiation, such as whole-body magnetic resonance imaging (MRI), could be a valid alternative; this would result an advantage, considering the young age of the majority of patients at diagnosis and the need to undergo to serial assessments. The recent introduction of combined PET total body MRI (PET/MRI) offers the possibility to integrate morphological information with the high resolution of MRI with the metabolic activity of PET, through the uptake of FDG, for a more accurate definition of the extent of disease in patients with lymphoma.
Detailed description
All patients diagnosed with classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma that meet the inclusion criteria will be enrolled in the study. They will undergo an FDG-PET/CT for defining the staging and the therapeutic strategy. PET/MRI scans will be performed immediately upon completion of the PET/contrast-enhanced CT study and FDG tracer will be injected before the PET/CT exam and PET/MRI acquisitions will be practiced using the residual activity of the tracer. All patients will have to provide their informed consent in order to participate in the study.
The combined assessment FDG-PET/CT and FDG-PET/MRI will be performed at diagnosis for staging, at the interim evaluation for early assessment of treatment response after 2 cycles of chemotherapy and finally the post-chemotherapy re-staging. The enrollment period is 24 months for a total of 60 patients with Hodgkin lymphoma and 60 with DLBC non Hodgkin lymphoma.
Patients enrolled in the study will be followed for the diagnostic/therapeutic program at the Hematology Department of Federico II University of Naples, while the FDG-PET/CT and FDG-PET/MRI examinations will be carried out at the IRCSS SDN of Naples. The acquired images will be evaluated by a panel of experienced radiologists and nuclear physicians at the IRCSS SDN Naples.
The results obtained from the examination MRI will not modify in any way the clinical therapeutic choices in the planned chemotherapy for the patient, who will not receive additional radiations. This prospective pilot study will be conducted after approval by the Ethics Committee; each patient will sign an appropriate informed consent.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hodgkin lymphoma patients | – | Diagnostic Test: FDG PET/TC and FDG PET/MRIHodgkin lymphoma patients with confirmed histological diagnosis |
| DLBC non Hodgkin lymphoma patients | – | Diagnostic Test: FDG PET/TC and FDG PET/MRIDLBC non Hodgkin lymphoma patients with confirmed histological diagnosis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients (>18 yrs) with histological diagnosis of classical Hodgkin lymphoma and non-Hodgkin diffuse large B-cell lymphoma.
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma;
- Age ≥18 years;
- The need of anti-neoplastic treatment;
- Written informed consent;
Key exclusion criteria (9 listed)
- Carriers of cardiac pacemakers;
- Carriers of metal mesh implants, tissue expanders (breast);
- Holders of metal implants, cochlear implants and stapedial prostheses, plates or screws, wires, nails, spinal-column distractors, ferromagnetic vascular clips, mechanical heart valves, Swan-Ganz catheter, endocorporal electrodes, neurostimulators, vascular filters, stents and metal spirals that they do not know the characteristics (the manufacturer, type and date of implant) and/or secure magnetic compatibility;
- Holders of metal fragments in the eye, visceral or intracranial;
- Tattoo holders executed by less than 6 months;
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 |
|---|---|---|
| FDG PET/TC and FDG PET/MRICombined assessment with FDG PET/TC and PET/MRI | Diagnostic test | DLBC non Hodgkin lymphoma patients, Hodgkin lymphoma patients |
Primary outcome
Diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation
Time frame: 1 year
Evaluate the diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation (early treatment response after 2 cycles of chemotherapy and final assessment) in patients with classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin lymphoma, as compared to conventional assessment by FDG PET/ contrast-enhanced CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- 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.
Fabrizio Pane, Prof principal investigator
Hematology - AOU Federico II - Naples - Italy
Marco Picardi, Prof study director
Hematology - AOU Federico II - Naples - Italy
Andrea Soricelli, Prof study chair
IRCSS SDN - Naples - Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-cell-lymphoma and Classical Hodgkin Lymphoma, run by Marco Picardi at 2 sites in Italy.
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 4 inclusion and 9 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Della Pepa, MD (+390817462037, roberta.dellapepa@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation (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 12 Jun 2020.