Methionine PET/CT Studies In Patients With Cancer

Neuroblastoma Clinical Trial

Official title:

Methionine PET/CT Studies In Patients With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00840047
• Other study ID #: METPET
• Secondary ID: NCI-2011-02414
• Status: Recruiting
• Phase: Phase 2
• Start date: July 20, 2009
• Est. completion date: July 27, 2027

Study information

• Verified date: July 2023
• Source: St. Jude Children's Research Hospital
• Contact: Barry L Shulkin, MD
• Phone: 1-866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: July 27, 2027
• Est. primary completion date: July 27, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Stem Glioma
• Brain Tumors and/or Solid Tumors Including
• Central Nervous System Neoplasms
• Craniopharyngioma
• Ependymoma
• Ewing Sarcoma
• High Grade CNS Tumors
• Hodgkin Lymphoma
• Low Grade CNS Tumors
• Lymphoma
• Medulloblastoma
• Neoplasms
• Neuroblastoma
• Non Hodgkin Lymphoma
• Osteosarcoma
• Other
• Rhabdomyosarcoma
• Sarcoma, Ewing

Intervention

Drug:
• Methionine
Intravenous injection

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	End of study (maximum of 3 years post methionine infusion and PET scan)
Secondary	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.	At baseline, after enrollment of the first 93 participants

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital