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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new drug, F-Glutamine, to see if it can be used with PET scanners to find tumors in patients.

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.Check my eligibility

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.See study design

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

Select...

I am between 21 and 90 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

pharmacokinetic profiles

Secondary outcome measures

bio distribution

metabolism

radiation dosimetry

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,813 Total Patients Enrolled

155 Trials studying Lymphoma

8,654 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

[18F] 4-L-Fluoroglutamine (2S,4R) Clinical Trial Eligibility Overview. Trial Name: NCT01697930 — Phase 1

Lymphoma Research Study Groups: [18F] 4-L-Fluoroglutamine (2S,4R)

Lymphoma Clinical Trial 2023: [18F] 4-L-Fluoroglutamine (2S,4R) Highlights & Side Effects. Trial Name: NCT01697930 — Phase 1

[18F] 4-L-Fluoroglutamine (2S,4R) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01697930 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research being offered to the general public?

"To qualify to join this medical trial, applicants must have a diagnosis of lymphoma and should be between 21 and 90 years old. The team is recruiting 85 participants in total."

Answered by AI

Is the age requirement for this research limited to those over eighteen years of age?

"For this medical trial, the age of eligibility falls between 21 and 90 years old."

Answered by AI

Is this research endeavor recruiting participants at present?

"The information on clinicaltrials.gov suggests that enrolment for this trial is ongoing, with the original posting date being September 1st 2012 and most recent update occurring on November 28th 2022."

Answered by AI

How many individuals can participate in this research endeavor?

"Confirmed. According to the clinicaltrials.gov website, this experiment is still searching for participants; it was first posted on September 1st 2012 and most recently revised on November 28th 2022. Eighty-five volunteers are needed from one medical site."

Answered by AI