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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 belowSelect...
I am between 21 and 90 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am willing and able to have an IV line for tests.
Select...
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
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.
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.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,977 Previous Clinical Trials
599,642 Total Patients Enrolled
156 Trials studying Lymphoma
9,184 Patients Enrolled for Lymphoma
Mark Dunphy, D.O.Principal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Lymphoma
11 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed cancer diagnosis and it can be measured for treatment response.My kidney function is below normal based on recent tests.I am willing and able to have an IV line for tests.I do not have any severe illnesses like heart problems.I am between 21 and 90 years old.
Research Study Groups:
This trial has the following groups:- Group 1: [18F] 4-L-Fluoroglutamine (2S,4R)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.