What side effects are associated with this type of intervention?

Common treatments for lymphoma, such as rituximab-based immunochemotherapy, can cause side effects including fatigue, nausea, loss of appetite, and increased risk of infections. Radioimmunotherapy with yttrium-90 ibritumomab tiuxetan may lead to myelotoxicity, which can result in conditions like myelodysplastic syndrome and acute leukemia. PET imaging agents, while generally safe, can sometimes cause mild reactions at the injection site or allergic reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

One notable FDA-approved treatment for lymphoma that involves imaging is the use of tositumomab and iodine-131 tositumomab. This treatment combines a monoclonal antibody (tositumomab) with a radioactive isotope (iodine-131) to target and destroy lymphoma cells, and it has been approved for patients with relapsed or refractory low-grade, follicular, or transformed low-grade non-Hodgkin's lymphoma. This approach is somewhat similar to the investigational use of 18F-Fluoroglutamine for PET imaging, as both involve radiolabeled compounds to detect or treat cancerous cells. Other FDA-approved treatments for lymphoma include various chemotherapeutic agents and monoclonal antibodies, such as rituximab, which is used to target CD20-positive B cells in non-Hodgkin's lymphoma.

What other types of research exist?

Promising alternatives to 18F-Fluoroglutamine for PET imaging in lymphoma patients include [(18)F]fludarabine, which has shown a strong correlation with histology in follicular lymphoma models, and L-(18)F-FAC and L-(18)F-FMAC, which have been validated for imaging leukemia and autoimmunity in animal models. These agents may offer improved specificity and diagnostic capabilities for lymphoma imaging.

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F-Glutamine PET Imaging for Cancer

Phase 1

Recruiting

Led By Mark Dunphy, D.O.

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 21-90

Be older than 18 years old

Must not have

Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [18F] 4-L-Fluoroglutamine (2S,4R) injection and blood draws.)

Acute major illness (e.g., unstable cardiovascular condition, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called F-Glutamine that helps find tumors using special scanners. It is aimed at patients who might have tumors. The drug is injected and tracked by the scanner to show where tumors might be. F-Glutamine has been evaluated for its safety in patients with metastatic colorectal cancer.

Who is the study for?

This trial is for adults aged 21-90 with confirmed solid tumors or lymphoma, which can be measured or evaluated. Women of childbearing age must have a negative pregnancy test and avoid unprotected sex during the study. Participants cannot join if they refuse IV lines, are breastfeeding, can't tolerate scans (like due to claustrophobia), have certain liver/renal conditions, or an acute major illness.

What is being tested?

[18F] 4-L-Fluoroglutamine (F-Glutamine) is being tested in this Phase I trial. It's a new drug used with PET scanners to detect where it travels in the body after injection. The goal is to see how long F-Glutamine stays in the blood and its distribution as a potential way to find tumors more effectively than current methods.

What are the potential side effects?

Since this is a first-in-human study of F-Glutamine, specific side effects are not yet known but may include reactions related to injection and PET scanning procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to have an IV line for tests.

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I do not have any severe illnesses like heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

pharmacokinetic profiles

Secondary study objectives

bio distribution

metabolism

radiation dosimetry

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F] 4-L-Fluoroglutamine (2S,4R)Experimental Treatment1 Intervention

This pilot, first in-human microdose PET trial of the positron-emitting agent \[18F\] 4-L-Fluoroglutamine (2S,4R) will be an open-label study. The \[18F\] 4-L-Fluoroglutamine (2S,4R) agent will be administered by bolus intravenous injection. In all study patients, the pharmacokinetics, metabolism, and biodistribution of \[18F\] 4-L-Fluoroglutamine (2S,4R) will be evaluated by non-invasive blood- and PET-based assays, at multiple time points (see Table 1,) during one day. Eligible patients optionally can participate in the study twice, on a separate date, receiving a second radiotracer microdose of \[18F\] 4-L-Fluoroglutamine (2S,4R), followed by non-invasive blood- and PET-based assays. At the discretion of the investigator, scan 3 can be waived.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lymphoma include chemotherapy, which kills rapidly dividing cancer cells; immunotherapy, which enhances the immune system's ability to fight cancer; radiation therapy, which uses high-energy rays to destroy cancer cells; and targeted therapy, which focuses on specific molecules within cancer cells. PET imaging, such as with 18F-Fluoroglutamine, plays a critical role in detecting and monitoring tumors, allowing for more precise and effective treatment plans. This is vital for lymphoma patients as it can lead to better-tailored treatments and improved outcomes.