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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether imaging with radiolabeled methionine can detect tumors in children and young adults. Methionine, a natural substance crucial for protein building, can be tracked in the body with a PET scan when tagged with a small amount of radioactive material. The trial aims to find tumors, monitor treatment progress, and distinguish between residual tumor and scar tissue post-treatment. Individuals with cancer or suspected cancer, already receiving care at St. Jude Children's Research Hospital, may qualify for this trial, especially if they have recently undergone certain imaging tests. As a Phase 2 trial, this research measures the imaging's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in cancer detection.

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 prior data suggests that this imaging technique is safe for children and young adults?

Research has shown that methionine, the treatment under study, is generally safe for humans. In a preliminary study, patients took methionine for about 17 weeks without major safety issues. Methionine, a natural amino acid found in diets, is essential for life.

None of methionine's components are identified as cancer-causing by OSHA, indicating it is not considered a cancer risk. However, in this study, methionine is used in a special form with a small amount of radioactivity. This helps doctors see tumors more clearly in imaging tests. The radioactivity is short-lived, limiting radiation exposure.

Although this trial is in an early stage, meaning more information is needed, current evidence suggests methionine is generally safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Methionine imaging is unique because it offers a new way to detect cancer by using methionine, an amino acid, to highlight tumors in imaging scans. Unlike traditional imaging methods, which might use glucose or other substances, methionine targets cancer cells more specifically due to their increased protein synthesis, potentially leading to clearer and more accurate detection of tumors. Researchers are excited about this approach because it could improve the precision of cancer diagnoses and help tailor treatments more effectively to individual patients.

What evidence suggests that methionine imaging is effective for cancer detection?

Research has shown that C-11 methionine (MET) PET scans excel at detecting cancer. Studies have found that MET-PET can identify various cancer types, including lung cancer. It is particularly useful for brain tumors, as it helps determine the tumor's severity. This imaging method effectively monitors cancer and evaluates treatment efficacy. These features make it a promising tool for assessing cancer without surgery. Participants in this trial will receive methionine to evaluate its effectiveness in cancer detection. ^{4 6 7 8 9}

Who Is on the Research Team?

Barry L Shulkin, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2949713225000023

Methionine restriction for cancer therapy: From preclinical ... Preclinical studies have revealed that MR effectively hinders cancer cell proliferation, triggers cell cycle arrest, and enhances the effectiveness of standard ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9185618/

Targeting the methionine addiction of cancer - PMC This review will explore new insights into the mechanisms of methionine dependence in cancer and therapeutic efforts to translate these insights into enhanced ...

3. mdpi.com mdpi.com/1424-8247/18/5/640

Methionine Dependency and Restriction in Cancer Subsequently, numerous studies have shown that 11C-methionine PET exhibits a pronounced capacity for detecting various cancer foci, including lung cancer, ...

4. mednexus.org mednexus.org/doi/abs/10.1016/j.cpt.2025.01.002

Methionine restriction for cancer therapy: From preclinical ... Preclinical studies have revealed that MR effectively hinders cancer cell proliferation, triggers cell cycle arrest, and enhances the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5672012/

Diagnostic and Prognostic Significance of Methionine ... The positive correlation of methionine uptake in low-grade brain tumors suggests that MET-PET can be used to estimate tumor malignancy in grade I–IV gliomas (35) ...

6. sigmaaldrich.com sigmaaldrich.com/sds/sial/m9625?srsltid=AfmBOookfVsTvPGfz4Vw0iVeJl_Vg_ET6L-6vfLcDo2A32_GQhVWImDx

• SAFETY DATA SHEET OSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens. Reproductive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7146589/

Methionine Restriction and Cancer Biology - PMC A feasibility study published in 2002 established that methionine restriction, provided enterally, for an average of 17 weeks is safe and feasible in patients ...

8. westliberty.edu westliberty.edu/health-and-safety/files/2017/07/DL-Methionine.pdf

DL-Methionine OSHA: No component of this product present at levels greater than or equal to 0.1% is identified as a carcinogen or potential carcinogen by OSHA. Reproductive ...

9. merck.com merck.com/docs/product/safety-data-sheets/ah-sds/Acetyl%20Methionine%20Formulation_AH_US_EN.pdf

Acetyl Methionine Formulation | Safety Data Sheets identified as a known or anticipated carcinogen by NTP. Reproductive toxicity. Not classified based on available information. Components: Nicotinamide: Effects ...