NCT03121456

Brief Summary

Open-label, multicenter, uncontrolled and non-randomized study comparing 18F-FDG PET-Scan and diffusion MRI in the assessment of the early therapeutic response of Diffuse Large B-Cell 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
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 13, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

6.5 years

First QC Date

April 12, 2017

Last Update Submit

November 9, 2023

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • measurement of the correlation between the Delta SUVmax in PET-TDM (or between the Deauville criteria if the Delta SUVmax is not applicable) and the Delta ADCmax in diffusion MRI.

    scattering MRI in the assessment of the early therapeutic response of diffuse large cell Lymphoma.

    up to 2 years

Secondary Outcomes (3)

  • progression free-survival at 2 years

    up to 2 years

  • diagnostic performance of MRI scattering

    Up to 4 years

  • - The degree of inter- and intra-observer association (concordance) of the ADCmax

    up to 4 years

Study Arms (1)

18F-FDG PET SCAN

EXPERIMENTAL

REALIZATION OF INITIAL 18F-FDG PET SCAN (PRE THERAPEUTIC), THEN BETWEEN CYCLE 2 DAY 10 AND CYCLE 3 DAY 1 MRI DIFFUSION REALIZATION OF INITIAL MRI DIFFUSION WITHIN 7 DAYS AFTER INITIAL 18F-FDG PET SCAN, THEN WITHIN 7 DAYS AFTER 18F-FDG PET SCAN 1.

Other: 18F-FDG PET SCANOther: MRI DIFFUSION

Interventions

18F-FDG PET SCANOTHER

REALIZATION OF INITIAL 18F-FDG PET SCAN (PRE THERAPEUTIC), THEN BETWEEN CYCLE 2 DAY 10 AND CYCLE 3 DAY 1

18F-FDG PET SCAN
MRI DIFFUSIONOTHER

REALIZATION OF INITIAL MRI DIFFUSION WITHIN 7 DAYS AFTER INITIAL 18F-FDG PET SCAN, THEN WITHIN 7 DAYS AFTER 18F-FDG PET SCAN 1.

18F-FDG PET SCAN

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with Diffuse Large B-Cell Lymphoma confirmed histologically
  • Patient with a tumor mass defined as measurable according to the RECIST 1.1 criteria,
  • Patient requiring a standard first-line chemotherapy treatment (Rituximab -Cyclophosphamide - Hydroxyadriamycin - Oncovin - Prednisone = R-CHOP every 21 days),
  • Patient older than 18 years,
  • Performance status less than or equal to 2,
  • Biological assessment meeting the following criteria: creatinine \<150 μmol / l or creatinine clearance\> 40 ml / min, total bilirubin \<30 μmol / l, transaminases \<2.5 x ULN
  • Patient of childbearing age must agree to use Means of effective contraception during the treatment period,
  • Patient having read the information note and having signed informed consent,
  • Patient with Health care insurance available.

You may not qualify if:

  • History of malignant hemopathy or solid tumor
  • History of previous chemotherapy
  • Contraindication to one of the examinations studied (Claustrophobia, Pacemaker ...)
  • Patient considered to be a vulnerable person; Vulnerable persons are defined in article L1121-5 to - 8: Pregnant women, women who are pregnant, women who are breastfeeding, Persons deprived of their liberty by a judicial or administrative decision, persons who are hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social institution for purposes other than research Persons who are the subject of a legal protection measure or are unable to give their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre antoine-LACASSAGNE

Nice, 06189, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Christine LOVERA

    Centre Antoine Lacassagne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 20, 2017

Study Start

October 13, 2017

Primary Completion

April 12, 2024

Study Completion

April 12, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

FR(1)