New imaging agent could help spot hidden tumors
NCT ID NCT01697930
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new radioactive drug called [18F] Fluoroglutamine, which is designed to be used with PET scanners. Researchers want to see how long it stays in the blood and where it goes in the body, especially whether it collects in tumors. 67 adults with solid cancers or lymphoma will receive a small injection and then have PET scans. The goal is to gather safety and imaging data, not to treat the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F] 4-L-Fluoroglutamine (2S,4R) (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could lead to a new way to spot tumors using PET scans, potentially improving cancer detection.
- What could go wrong
- This is a very early Phase I study with only 67 people, focused on safety and imaging, not on treating cancer. It may not prove better than current scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
67 people
The number who actually took part.
- Start date
-
Sep 2012
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 90 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with history of histologically-confirmed solid malignancy and/or lymphoma (histology confirmed by MSKCC Department of Pathology.) Disease measurable or evaluable as defined by RECIST 1.1 or other tumor response criteria from an MSKCC IRB-approved clinical research protocol. NOTE: Study patients do not need to be participating in an MSKCC approved clinical trial prior to study recruitment. * Age between 21-90 * Negative serum pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from assays obtained \<2 weeks prior to study enrollment. Patients will be advised against having unprotected sexual intercourse from the time of the negative serum pregnancy test until after completing their participation in the study. Exclusion Criteria: * 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.) * Breast-feeding * Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia) * Hepatic: from assays obtained \<2 weeks prior to study enrollment For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay. * Bilirubin \> 1.5 x (ULN) * AST/ALT \>2.5 x ULN * Albumin \< 3 g/dl * GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN. * Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained \<2 weeks prior to study enrollment * Acute major illness (e.g., unstable cardiovascular condition, etc.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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