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
Last Update Posted : October 21, 2016
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular and Whole-body MR Imaging in Lymphomas|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||September 2016|
Other: 68Ga-DOTANOC PET/CT; Diffusion weighted MRI
PET/CT: Radionuclide imaging using short-lived isotope Ga-68; MRI imaging w/o gadolinium contrast
- 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
- 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
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
|Turku University Hospital|
|Turku, Finland, 20521|
|Study Chair:||Juhani Knuuti, M.D., Ph.D.||Turku PET Centre|