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

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ClinicalTrials.gov Identifier: NCT02389101
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin Other: 68Ga-DOTANOC PET/CT; Diffusion weighted MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular and Whole-body MR Imaging in Lymphomas
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lymphoma
Newly diagnosed lymphoma, all subtypes allowed
Other: 68Ga-DOTANOC PET/CT; Diffusion weighted MRI
PET/CT: Radionuclide imaging using short-lived isotope Ga-68; MRI imaging w/o gadolinium contrast




Primary Outcome Measures :
  1. 68Ga-DOTANOC Uptake in Lymphomas With PET/CT [ Time Frame: Within 30 days prior to start of chemotherapy ]
    Uptake of 68Ga-DOTANOC in lymphoma expressed as SUVmax



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

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Responsible Party: Heikki Minn, Professor, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02389101    
Other Study ID Numbers: T164/2014
First Posted: March 17, 2015    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
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Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases