Methionine Imaging for Cancer Detection

Overseen By Barry L Shulkin, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: More than 6 MET PET scans, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

503 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Methionine for cancer detection?

Research shows that Methionine, particularly in its labeled form for PET scans, is effective in detecting various types of tumors, including lung and brain tumors, by highlighting areas of increased amino acid metabolism, which is often higher in cancerous tissues. ^{1 2 3 4 5}

Is methionine imaging safe for humans?

The research articles focus on the use of methionine in imaging for cancer detection, but they do not provide specific safety data for humans. Methionine has been used in various imaging studies, but the safety information is not detailed in these abstracts. ^{4 5 6 7 8}

How does methionine imaging differ from other cancer detection methods?

Methionine imaging is unique because it uses methionine, an amino acid, as a tracer in PET scans to detect cancer by highlighting areas of increased amino acid metabolism, which is common in tumors. This method can be particularly useful for identifying tumors with low growth rates that might not be detected by standard imaging techniques. ^{1 4 6 7 9}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline PET/CT scans using methionine to visualize tumors

1 week

1 visit (in-person)

Treatment/Observation

Participants receive methionine and undergo PET/CT scans to evaluate tumor response and biodistribution

Up to 3 years

Multiple visits (in-person) over 3 years

Follow-up

Participants are monitored for safety and effectiveness after methionine PET/CT scans

4 weeks

Treatment Details

Interventions

• Methionine

Trial Overview The 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

Group I: Participants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Lung tumor imaging by positron emission tomography using C-11 L-methionine. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Imaging of head and neck tumors with positron emission tomography and [11C]methionine. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Relationship between histologic type of primary lung cancer and carbon-11-L-methionine uptake with positron emission tomography. [2016]

4. Hungary pubmed.ncbi.nlm.nih.gov

[11C-methionine: an effective radio-tracer for PET scan in the detection of tumors of low proliferating capacity]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of 99mTc-L-methionine brain SPECT for detection of recurrent brain tumor: a pilot study with radiological and pathological correlation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Metal based imaging probes of DO3A-Act-Met for LAT1 mediated methionine specific tumors: synthesis and preclinical evaluation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Imaging of uterine carcinoma by carbon-11-methionine and PET. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Carbon-11-methionine PET imaging of malignant melanoma. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Synthesis of a Novel IR-822-Met near-infrared probe for in vivo tumor diagnosis. [2017]