Methionine PET/CT Studies In Patients With Cancer

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Methionine PET/CT Studies In Patients With Cancer

Study Purpose

The purpose of this study is to test the usefulness of imaging with radiolabeled methionine in the evaluation of children and young adults with tumor(s). Methionine is a naturally occurring essential amino acid. It is crucial for the formation of proteins. When labeled with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the distribution of methionine can be determined noninvasively using a PET (positron emission tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be produced in a facility very close to its intended use. Thus, it is not widely available and is produced only at select institutions with access to a cyclotron and PET chemistry facility. With the new availability of short lived tracers produced by its PET chemistry unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with the capabilities and interests to evaluate the utility of PET scanning in the detection of tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue in patients who have completed therapy. The investigators propose to examine the biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary purpose of this proposal, the investigators anticipate that MET studies will provide useful clinical information for the management of patients with malignant neoplasms.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation.

- Participants will have had, or are scheduled to have clinical imaging evaluations which may include FDG PET CT, or CT, or MRI within 4 weeks of entry.

- No limit on age or gender.

- Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.

- Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.

Exclusion Criteria:

- More than 6 MET PET scans within the previous 12 months.

- Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent.

Inclusion Criteria for Open-Access.

- All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation.

- No limit on age or gender.

- Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.

- Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.

Exclusion Criteria for Open-Access.

- More than 6 MET PET scans within the previous 12 months.

- Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00840047
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St. Jude Children's Research Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Barry L Shulkin, MD
Principal Investigator Affiliation	St. Jude Children's Research Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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
Study Website:	View Trial Website

Additional Details

The study focuses on the following objectives: Primary objective:

- 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. Secondary objective:

- 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.

Exploratory objectives:

- 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.

Arms & Interventions

Arms

Experimental: Participants

Participants who meet the eligibility criteria in the study will receive methionine.

Interventions

Drug: - Methionine

Intravenous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38119