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Methionine PET/CT Studies In Patients With Cancer

Primary Purpose

Brain Tumors and/or Solid Tumors Including, Brain Stem Glioma, High Grade CNS Tumors

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methionine
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumors and/or Solid Tumors Including focused on measuring Pediatric brain tumor, Pediatric solid tumor, Pediatric solid neoplasms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Jude Children's Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

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

Outcomes

Primary Outcome Measures

Success rate of methionine (MET) for visualizing tumors
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
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
Whole body scans will be acquired and descriptive statistics for MET uptake from other parts of the body will be provided.

Full Information

First Posted
February 9, 2009
Last Updated
July 5, 2023
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00840047
Brief Title
Methionine PET/CT Studies In Patients With Cancer
Official Title
Methionine PET/CT Studies In Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2009 (Actual)
Primary Completion Date
July 27, 2027 (Anticipated)
Study Completion Date
July 27, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Pediatric brain tumor, Pediatric solid tumor, Pediatric solid neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Participants who meet the eligibility criteria in the study will receive methionine.
Intervention Type
Drug
Intervention Name(s)
Methionine
Other Intervention Name(s)
MET, [11C]-L-Methionine
Intervention Description
Intravenous injection
Primary Outcome Measure Information:
Title
Success rate of methionine (MET) for visualizing tumors
Description
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
Baseline
Secondary Outcome Measure Information:
Title
Association of methionine uptake with tumor grade
Description
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.
Time Frame
End of study (maximum of 3 years post methionine infusion and PET scan)
Title
Bio-distribution of MET in organs
Description
Whole body scans will be acquired and descriptive statistics for MET uptake from other parts of the body will be provided.
Time Frame
At baseline, after enrollment of the first 93 participants

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barry L Shulkin, MD
Phone
1-866-278-5833
Email
referralinfo@stjude.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry L Shulkin, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry L Shulkin, MD
Phone
866-278-5833
Email
referralinfo@stjude.org
First Name & Middle Initial & Last Name & Degree
Barry L Shulkin, MD

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

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Methionine PET/CT Studies In Patients With Cancer

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