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Molecular and Whole-body MR Imaging in Lymphomas (MILY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02389101
First Posted: March 17, 2015
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital
  Purpose

Lymphomas are classified as Hodgkin's or non-Hodgkin's lymphomas, of which especially the latter represent a heterogeneous group with varying patterns of prognosis, biological behaviour and response to treatment. 18F-FDG PET/CT is useful for staging and response monitoring but has the disadvantage of associated radiation exposure which may not be desirable for young patients. Advanced MRI techniques including diffusion weighted imaging (DWI) are increasingly used for improved lesion detection and characterisation of lymphomas and in the whole-body mode offer a promising radiation-free alternative to CT. Molecular imaging in turn is important in theranostics medicine where detection of therapeutic target is essential. The concept of theranostics has been successfully adapted to management of neuroendocrine tumors (NET) where peptide receptor radiotherapy (PRRT) is offered to patients progressing on treatment with long-acting somatostatin analogues.

Recently in the investigator's hospital a case of diffuse large B-cell lymphoma (DLBCL) was initially misdiagnosed as NET because of high uptake of 68Ga-DOTANOC in pancreatic tumor at PET/CT. A PubMed search revealed a similar case report in bronchial tumor which turned out to be DLBCL (Jain et al. Clin Nucl Med 2014;39:358-359). Bearing these two cases in mind the investigators now aim to systematically study somatostatin receptor status (ssr) by measuring uptake of 68Ga-DOTANOC with PET/CT in patients with newly diagnosed non-Hodgkin's and Hodgkin's lymphoma. The imaging findings will be compared to immunohistochemically determined ssr-subtypes 2,3 and 5 obtained from pre-treatment fresh tumor samples and 18F-FDG PET/CT which is part of standard diagnostic evaluation. Furthermore, whole-body MRI with DWI will be performed before, during and after chemotherapy to define the most sensitive and specific imaging method appropriate for routine diagnosis and follow-up. This study has potential implications for future response monitoring and follow-up imaging techniques in patients with malignant lymphoma and provides additional biologic characterization which may be useful for novel therapeutic approaches such as PRRT.


Condition Intervention
Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin Other: 68Ga-DOTANOC PET/CT; Diffusion weighted MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular and Whole-body MR Imaging in Lymphomas

Resource links provided by NLM:


Further study details as provided by Heikki Minn, Turku University Hospital:

Primary Outcome Measures:
  • 68Ga-DOTANOC uptake in lymphomas with PET/CT [ Time Frame: Within 30 days prior to start of chemotherapy ]
    Different uptake values in lymphoma tissue (e.g. SUVmax, SUVmean, binding potential) will be measured and correlated with immunohistochemically determined somatostatin receptor status, lymphoma aggressiveness, tissue biomarkers, and uptake in 18F-FDG PET/CT

  • Agreement between DWI-MRI and 18F-FDG PET/CT at diagnosis [ Time Frame: Within 30 days prior to start of chemotherapy ]
    Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT at diagnosis

  • Agreement between DWI-MRI and 18F-FDG PET/CT in follow-up examinations [ Time Frame: 2 weeks after the 6th cycle of chemotherapy ]
    Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT after completion of chemotherapy for treatment response assessment


Secondary Outcome Measures:
  • Diffusion weighted MR parameters in the lymphoma tissue [ Time Frame: Within 30 days prior to start of chemotherapy ]
    Different diffusion values (eg. ADCm, ADCk) will be measured in lymphoma tissue and correlated with lymphoma aggressiveness, tissue biomarkers, and uptake in 18F-FDG PET/CT.

  • Changes in diffusion weighted MR parameters in the lymphoma tissue during chemotherapy [ Time Frame: 2 weeks after the 2nd cycle of chemotherapy ]
    Change in different MR diffusion values (eg. ADCm, ADCk) during and after chemotherapy will be estimated from repeated MRI examinations and correlated to 18F-FDG PET/CT

  • Changes in diffusion weighted MR parameters in the lymphoma tissue after chemotherapy [ Time Frame: 2 weeks after the 6th cycle of chemotherapy ]
    Change in different MR diffusion values (eg. ADCm, ADCk) during and after chemotherapy will be estimated from repeated MRI examinations and correlated to 18F-FDG PET/CT


Enrollment: 21
Study Start Date: October 2014
Study Completion Date: September 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lymphoma Other: 68Ga-DOTANOC PET/CT; Diffusion weighted MRI
PET/CT: Radionuclide imaging using short-lived isotope Ga-68; MRI imaging w/o gadolinium contrast

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-75 years old
  • Language spoken: Finnish or Swedish
  • Patients with diagnosed untreated non-Hodgkin's or Hodgkin's lymphoma with measurable disease (the diagnosis is based on radiological, histological and clinical grounds)
  • Before treatment CT and FDG-PET performed
  • Mental status: Patients must be able to understand the meaning of the study
  • The patient signs the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • Any medical or psychiatric condition that compromises the subject's ability to participate in the study
  • Any other significant disease including liver or renal disease
  • Pregnant or lactating women
  • Contraindications for MR imaging
  Contacts and Locations
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): NCT02389101


Locations
Finland
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
Study Chair: Juhani Knuuti, M.D., Ph.D. Turku PET Centre
  More Information

Publications:

Responsible Party: Heikki Minn, Professor, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02389101     History of Changes
Other Study ID Numbers: T164/2014
First Submitted: October 22, 2014
First Posted: March 17, 2015
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Heikki Minn, Turku University Hospital:
Lymphoma
68Ga-DOTANOC PET/CT
Somatostatin receptor
MRI
Diffusion weighted imaging
Early treatment response

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