Methionine PET/CT Studies In Patients With Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00840047|
Recruitment Status : Recruiting
First Posted : February 10, 2009
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors and/or Solid Tumors Including Brain Stem Glioma High Grade CNS Tumors Ependymoma Medulloblastoma Craniopharyngioma Low Grade CNS Tumors Hodgkin Lymphoma Non Hodgkin Lymphoma Ewing Sarcoma Osteosarcoma Rhabdomyosarcoma Neuroblastoma Other||Drug: Methionine||Phase 2|
The study focuses on the following objectives:
- To estimate the success rate of Methionine (MET) for visualizing tumors at the time of diagnosis. The study hypothesizes that at least 70% of newly diagnosed tumors within each group will be studied and will be successfully visualized.
- To compare uptake of MET in tumors with tumor grade in patients with newly diagnosed or relapsed, and/or persistent disease. Hypothesis: high grade tumors will concentrate higher amounts of MET than lower grade tumors measured both qualitatively and semi-quantitatively.
- To examine the bio-distribution of MET in organs that do not contain tumor, in particular the lungs, heart, mediastinum, liver, spleen, pancreas, muscle, brain, and bone marrow.
- To compare the findings on MET PET scans with those of standard imaging modalities, principally MRI (magnetic resonance imaging) and FDG (fluorodeoxyglucose) PET CT (computed tomography) at diagnosis, or at study enrollment for patients with relapsed and or persistent disease, and for all patients over time.
- To compare the extent of abnormality on MRI with that of MET.
- To determine the presence or absence of elevated MET uptake beyond those of MRI defined abnormality.
- To explore the relationship between MET uptake and prognosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||650 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Methionine PET/CT Studies In Patients With Cancer|
|Actual Study Start Date :||July 20, 2009|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2023|
Participants who meet the eligibility criteria in the study will receive methionine.
- Success rate of methionine (MET) for visualizing tumors [ Time Frame: Baseline ]To estimate the success rate of methionine (MET) for visualizing tumors at the time of diagnosis. We hypothesize that at least 70% of tumors within each group studied will be successfully visualized.
- Association of methionine uptake with tumor grade [ Time Frame: End of study (maximum of 3 years post methionine infusion and PET scan) ]Methionine uptake in tumors will be compared among tumor grades in patients with newly diagnosed or relapsed, and/or persistent disease. Hypothesis: high-grade tumors will concentrate higher amounts of MET than lower-grade tumors measured both qualitatively and semi-quantitatively.
- Bio-distribution of MET in organs [ Time Frame: At baseline, after enrollment of the first 93 participants ]Whole body scans will be acquired and descriptive statistics for MET uptake from other parts of the body will be provided.
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): NCT00840047
|Contact: Barry L Shulkin, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38119|
|Contact: Barry L Shulkin, MD 866-278-5833 email@example.com|
|Principal Investigator: Barry L Shulkin, MD|
|Principal Investigator:||Barry L Shulkin, MD||St. Jude Children's Research Hospital|