Methionine Imaging for Cancer Detection

Recruiting in Palo Alto (17 mi)

Overseen byBarry L Shulkin, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Barry L Shulkin, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for children and young adults with various types of cancer, including brain tumors and sarcomas. Participants can be any age or gender, must not be breastfeeding if they are of childbearing age, have consented to the study, and are under the care of St. Jude physicians.

Inclusion Criteria

Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.

I have had, or will have, a scan like PET, CT, or MRI within the next 4 weeks.

I am not breastfeeding as I might need to undergo treatments involving radiation.

See 2 more

Exclusion Criteria

Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent.

More than 6 MET PET scans within the previous 12 months.

Treatment Details

Interventions

Methionine (Amino Acid)

Trial OverviewThe trial is testing a diagnostic imaging technique using C-11 methionine (MET) with PET/CT scans to evaluate tumor presence and response to therapy in patients with malignant solid neoplasms, focusing on CNS tumors and sarcomas.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ParticipantsExperimental Treatment1 Intervention

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