<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042247</url>
  </required_header>
  <id_info>
    <org_study_id>FDGMR-LIN</org_study_id>
    <nct_id>NCT03042247</nct_id>
  </id_info>
  <brief_title>Prospective Comparison Between FDG-PET/MR and FDG-PET/CT in Classical Hodgkin Lymphoma and DLBC Non-Hodgkin Lymphoma</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marco Picardi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to the most recent guidelines, total-body imaging techniques are an indispensable&#xD;
      element in the staging and post-treatment re-evaluation in patients with lymphoma.&#xD;
      Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the&#xD;
      gold-standard for the assessment of the disease in these patients. The use of alternative&#xD;
      methods, without radiation, such as whole-body magnetic resonance imaging (MRI), could be a&#xD;
      valid alternative; this would result an advantage, considering the young age of the majority&#xD;
      of patients at diagnosis and the need to undergo to serial assessments. The recent&#xD;
      introduction of combined PET total body MRI (PET/MRI) offers the possibility to integrate&#xD;
      morphological information with the high resolution of MRI with the metabolic activity of PET,&#xD;
      through the uptake of FDG, for a more accurate definition of the extent of disease in&#xD;
      patients with lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients diagnosed with classical Hodgkin lymphoma and diffuse large B-cell non-Hodgkin&#xD;
      lymphoma that meet the inclusion criteria will be enrolled in the study. They will undergo an&#xD;
      FDG-PET/CT for defining the staging and the therapeutic strategy. PET/MRI scans will be&#xD;
      performed immediately upon completion of the PET/contrast-enhanced CT study and FDG tracer&#xD;
      will be injected before the PET/CT exam and PET/MRI acquisitions will be practiced using the&#xD;
      residual activity of the tracer. All patients will have to provide their informed consent in&#xD;
      order to participate in the study.&#xD;
&#xD;
      The combined assessment FDG-PET/CT and FDG-PET/MRI will be performed at diagnosis for&#xD;
      staging, at the interim evaluation for early assessment of treatment response after 2 cycles&#xD;
      of chemotherapy and finally the post-chemotherapy re-staging. The enrollment period is 24&#xD;
      months for a total of 60 patients with Hodgkin lymphoma and 60 with DLBC non Hodgkin&#xD;
      lymphoma.&#xD;
&#xD;
      Patients enrolled in the study will be followed for the diagnostic/therapeutic program at the&#xD;
      Hematology Department of Federico II University of Naples, while the FDG-PET/CT and&#xD;
      FDG-PET/MRI examinations will be carried out at the IRCSS SDN of Naples. The acquired images&#xD;
      will be evaluated by a panel of experienced radiologists and nuclear physicians at the IRCSS&#xD;
      SDN Naples.&#xD;
&#xD;
      The results obtained from the examination MRI will not modify in any way the clinical&#xD;
      therapeutic choices in the planned chemotherapy for the patient, who will not receive&#xD;
      additional radiations. This prospective pilot study will be conducted after approval by the&#xD;
      Ethics Committee; each patient will sign an appropriate informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation</measure>
    <time_frame>1 year</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Diffuse Large B-cell-lymphoma</condition>
  <condition>Classical Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Hodgkin lymphoma patients</arm_group_label>
    <description>Hodgkin lymphoma patients with confirmed histological diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DLBC non Hodgkin lymphoma patients</arm_group_label>
    <description>DLBC non Hodgkin lymphoma patients with confirmed histological diagnosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FDG PET/TC and FDG PET/MRI</intervention_name>
    <description>Combined assessment with FDG PET/TC and PET/MRI</description>
    <arm_group_label>DLBC non Hodgkin lymphoma patients</arm_group_label>
    <arm_group_label>Hodgkin lymphoma patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Patients (&gt;18 yrs) with histological diagnosis of classical Hodgkin lymphoma and&#xD;
        non-Hodgkin diffuse large B-cell lymphoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of classical Hodgkin lymphoma and diffuse large&#xD;
             B-cell non-Hodgkin lymphoma;&#xD;
&#xD;
          -  Age ≥18 years;&#xD;
&#xD;
          -  The need of anti-neoplastic treatment;&#xD;
&#xD;
          -  Written informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Carriers of cardiac pacemakers;&#xD;
&#xD;
          -  Carriers of metal mesh implants, tissue expanders (breast);&#xD;
&#xD;
          -  Holders of metal implants, cochlear implants and stapedial prostheses, plates or&#xD;
             screws, wires, nails, spinal-column distractors, ferromagnetic vascular clips,&#xD;
             mechanical heart valves, Swan-Ganz catheter, endocorporal electrodes,&#xD;
             neurostimulators, vascular filters, stents and metal spirals that they do not know the&#xD;
             characteristics (the manufacturer, type and date of implant) and/or secure magnetic&#xD;
             compatibility;&#xD;
&#xD;
          -  Holders of metal fragments in the eye, visceral or intracranial;&#xD;
&#xD;
          -  Tattoo holders executed by less than 6 months;&#xD;
&#xD;
          -  Claustrophobic patients;&#xD;
&#xD;
          -  Pregnant patients;&#xD;
&#xD;
          -  Patients with uncontrolled diabetes mellitus;&#xD;
&#xD;
          -  Patients who do not provide written informed consent to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrizio Pane, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hematology - AOU Federico II - Naples - Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Picardi, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Hematology - AOU Federico II - Naples - Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea Soricelli, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>IRCSS SDN - Naples - Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roberta Della Pepa, MD</last_name>
    <phone>+390817462037</phone>
    <email>roberta.dellapepa@unina.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Prof Marco Picardi</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberta Della Pepa, MD</last_name>
      <phone>+390817462037</phone>
      <email>roberta.dellapepa@unina.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prof Marco Picardi - Hematology - AOU FEDERICO II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberta Della Pepa, MD</last_name>
      <phone>+390817462037</phone>
      <email>roberta.dellapepa@unina.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Marco Picardi</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042247
org study id: FDGMR-LIN
nct id: NCT03042247
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Diagnostic accuracy in terms of sensitivity and specificity of FDG-PET/MRI in the staging and post-chemotherapy revaluation
time frame: 1 year
description: 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
arm group label: Hodgkin lymphoma patients
description: Hodgkin lymphoma patients with confirmed histological diagnosis
arm group label: DLBC non Hodgkin lymphoma patients
description: DLBC non Hodgkin lymphoma patients with confirmed histological diagnosis
intervention type: Diagnostic Test
intervention name: FDG PET/TC and FDG PET/MRI
description: Combined assessment with FDG PET/TC and PET/MRI
arm group label: DLBC non Hodgkin lymphoma patients
arm group label: Hodgkin lymphoma patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Fabrizio Pane, Prof
role: Principal Investigator
affiliation: Hematology - AOU Federico II - Naples - Italy
last name: Marco Picardi, Prof
role: Study Director
affiliation: Hematology - AOU Federico II - Naples - Italy
last name: Andrea Soricelli, Prof
role: Study Chair
affiliation: IRCSS SDN - Naples - Italy
last name: Roberta Della Pepa, MD
phone: +390817462037
email: roberta.dellapepa@unina.it
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: Federico II University
investigator full name: Marco Picardi
investigator title: Prof.
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hodgkin Disease
mesh term: Lymphoma, Large B-Cell, Diffuse
sharing ipd: Undecided