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A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)

Phase 1
21 Years
90 Years
Open (Enrolling)
Solid Malignancy, Lymphoma

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Trial Information

A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)

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.)

- Patients with diabetes mellitus that are taking diabetes medication at the time of
the study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

pharmacokinetic profiles

Outcome Description:

The trial-design follows standard guidelines on collecting pharmacokinetic (PK) data for investigational radioactive drugs.1, 29-36 Animal [18F] 4-L-of [18F] 4-L-Fluoroglutamine (2S,4R). Fluoroglutamine (2S,4R) PK data provided a basis for the trial design. Sampling time-points were chosen (1) by anticipated exponential PK; with (2) allometry-based interspecies extrapolation of time-scales.37 As data is available from the first patients, suitability of the time-points will be re-examined. Blood samples will be centrifuged and the plasma pipetted, weighed and counted to determine the plasma time activity concentration curves (% injected dose/liter), as well as for metabolite analysis of the [18F] 4-L-Fluoroglutamine (2S,4R) compound (by radio-HPLC or other fit-forpurpose methodology).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mark Dunphy, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Solid Malignancy
  • Lymphoma
  • PET Imaging
  • 18F] 4-L-Fluoroglutam (2S,4R)
  • 12-168
  • Neoplasms
  • Lymphoma



Memorial Sloan Kettering Cancer Center New York, New York  10021