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Methionine PET/CT Studies In Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00840047
Recruitment Status : Recruiting
First Posted : February 10, 2009
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE July 20, 2009
Estimated Primary Completion Date July 27, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
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. [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methionine PET/CT Studies In Patients With Cancer
Official Title  ICMJE Methionine PET/CT Studies In Patients With Cancer
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: Methionine
Intravenous injection
Other Names:
  • MET
  • [11C]-L-Methionine
Study Arms  ICMJE Experimental: Participants
Participants who meet the eligibility criteria in the study will receive methionine.
Intervention: Drug: Methionine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
650
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
350
Estimated Study Completion Date  ICMJE July 27, 2027
Estimated Primary Completion Date July 27, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barry L Shulkin, MD 1-866-278-5833 referralinfo@stjude.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840047
Other Study ID Numbers  ICMJE METPET
NCI-2011-02414 ( Registry Identifier: NCI Clinical Trial Registration Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry L Shulkin, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP