NCT03042247

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

January 24, 2017

Last Update Submit

June 10, 2020

Conditions

Diffuse Large B-cell-lymphomaClassical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Study Arms (2)

Hodgkin lymphoma patients

Hodgkin lymphoma patients with confirmed histological diagnosis

Diagnostic Test: FDG PET/TC and FDG PET/MRI

DLBC non Hodgkin lymphoma patients

DLBC non Hodgkin lymphoma patients with confirmed histological diagnosis

Diagnostic Test: FDG PET/TC and FDG PET/MRI

Interventions

FDG PET/TC and FDG PET/MRIDIAGNOSTIC_TEST

Combined assessment with FDG PET/TC and PET/MRI

DLBC non Hodgkin lymphoma patientsHodgkin lymphoma patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Patients (\>18 yrs) with histological diagnosis of classical Hodgkin lymphoma and non-Hodgkin diffuse large B-cell lymphoma.

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • Pregnant patients;
  • Patients with uncontrolled diabetes mellitus;
  • Patients who do not provide written informed consent to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prof Marco Picardi

Naples, 80131, Italy

RECRUITING

Prof Marco Picardi - Hematology - AOU FEDERICO II

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Fabrizio Pane, Prof

    Hematology - AOU Federico II - Naples - Italy

    PRINCIPAL INVESTIGATOR

  • Marco Picardi, Prof

    Hematology - AOU Federico II - Naples - Italy

    STUDY DIRECTOR

  • Andrea Soricelli, Prof

    IRCSS SDN - Naples - Italy

    STUDY CHAIR

Central Study Contacts

Roberta Della Pepa, MD

CONTACT

+390817462037roberta.dellapepa@unina.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 3, 2017

Study Start

January 24, 2017

Primary Completion

June 10, 2020

Study Completion

February 1, 2021

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

IT(2)