Methionine PET/CT Studies In Patients With Cancer

  • STATUS
    Recruiting
  • End date
    Jul 27, 2027
  • participants needed
    650
  • sponsor
    St. Jude Children's Research Hospital
Updated on 4 October 2022
cancer
MRI
residual tumor
positron emission tomography
sarcoma
nervous
fdg pet
PET-CT
essential amino acid

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.

Details
Condition 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
Treatment Methionine, Methionine
Clinical Study IdentifierNCT00840047
SponsorSt. Jude Children's Research Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note