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Detection and Characterization of Residual Masses in Lymphomas (ADAMANTIUS)

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ClinicalTrials.gov Identifier: NCT02300402
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Brief 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 determine the added value of whole-body DWI to Fluorodeoxyglucose-PET for the management of lymphoma patients.

Condition or disease
Hodgkin Lymphoma B-Cell Lymphoma

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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. correlation between the PET and MR-derived functional parameters with clinical outcome (end-treatment response and survival) [ Time Frame: Between 18 and 24 weeks ]

Other Outcome Measures:
  1. development of automated lesion detection algorithm [ Time Frame: Baseline, 6 weeks, between 18 and 24 weeks ]
  2. texture analysis of the major lymphoma mass and correlation of tumor heterogeneity with treatment outcome [ Time Frame: Baseline, 6 weeks, between 18 and 24 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed HL, DLBCL or FL At least 18 years of age Initial presentation of bulky disease
Criteria

Inclusion Criteria:

  • Newly diagnosed hodgkin's lymphoma, diffuse large B-cell lymphoma or follicular lymphoma
  • Patients aged over 18
  • Initial presentation of bulky disease

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300402


Contacts
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Contact: Romain RR Ricci +33145178073 romain.ricci@lysarc.org

Locations
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France
Hopital Henri Mondor Recruiting
Créteil, France, 94010
Principal Investigator: Corinne HAIOUN, Pr         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
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Principal Investigator: Alain Rahmouni, Prof. CHU Henri Mondor
Principal Investigator: Corinne Haioun, Prof. Lymphoma Study Association
Principal Investigator: Emmanuel Itti, Prof. CHU Henri Mondor

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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT02300402     History of Changes
Other Study ID Numbers: ADAMANTIUS
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin