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Methionine PET/CT Studies In Patients With Cancer

This study is currently recruiting participants.
Verified May 2017 by St. Jude Children's Research Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840047
First Posted: February 10, 2009
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  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.

Condition Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Methionine PET/CT Studies In Patients With Cancer

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 650
Actual Study Start Date: July 20, 2009
Estimated Study Completion Date: May 31, 2023
Estimated Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants
Participants who meet the eligibility criteria in the study will receive methionine.
Drug: Methionine
Intravenous injection
Other Names:
  • MET
  • [11C]-L-Methionine

Detailed Description:

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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): NCT00840047


Contacts
Contact: Barry L Shulkin, MD 1-866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38119
Contact: Barry L Shulkin, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Barry L Shulkin, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Barry L Shulkin, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00840047     History of Changes
Other Study ID Numbers: METPET
NCI-2011-02414 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Submitted: February 9, 2009
First Posted: February 10, 2009
Last Update Posted: May 11, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Pediatric brain tumor
Pediatric solid tumor
Pediatric solid neoplasms

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Hodgkin Disease
Brain Neoplasms
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Ependymoma
Sarcoma, Ewing
Medulloblastoma
Craniopharyngioma
Adamantinoma
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial