Methionine PET/CT Studies In Patients With Cancer

July 5, 2023 updated by: St. Jude Children's Research Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

650

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • St. Jude Children's Research Hospital
        • Contact:
        • Principal Investigator:
          • Barry L Shulkin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
Participants who meet the eligibility criteria in the study will receive methionine.
Drug: Methionine
Intravenous injection
Other Names:
  • MET
  • [11C]-L-Methionine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of study (maximum of 3 years post methionine infusion and PET scan)
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.
At baseline, after enrollment of the first 93 participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Barry L Shulkin, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2009

Primary Completion (Estimated)

July 27, 2027

Study Completion (Estimated)

July 27, 2027

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimated)

February 10, 2009

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METPET
  • NCI-2011-02414 (Registry Identifier: NCI Clinical Trial Registration Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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