Clinical trial NCT01697930: A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)
Official title: A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Malignancy
Lymphoma
Keywords: PET Imaging
18F] 4-L-Fluoroglutam (2S,4R)
12-168
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 85
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a Phase I study. This study is the first time that a new experimental drug called 18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its injected. PET scanners are one of the kinds of scanners you normally find in a hospital radiology department. The researchers have found that tumors in animals absorb F-Glutamine. The researchers believe that scans with F-Glutamine might be able to find tumors in patients.

This first in-human study is being done to see how long F-Glutamine lasts in the blood, when it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in the body. If the results of this trial are good, then the study doctors plan to use F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors compared to the standard types of scans that doctors use.


Eligibility criteria: 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.)

Primary outcomes:
measure: pharmacokinetic profiles
timeFrame: 2 years
Secondary outcomes:
measure: metabolism
timeFrame: 2 years
measure: bio distribution
timeFrame: 2 years
measure: radiation dosimetry
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Dunphy, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunphy MPS, Harding JJ, Venneti S, Zhang H, Burnazi EM, Bromberg J, Omuro AM, Hsieh JJ, Mellinghoff IK, Staton K, Pressl C, Beattie BJ, Zanzonico PB, Gerecitano JF, Kelsen DP, Weber W, Lyashchenko SK, Kung HF, Lewis JS. In Vivo PET Assay of Tumor Glutamine Flux and Metabolism: In-Human Trial of 18F-(2S,4R)-4-Fluoroglutamine. Radiology. 2018 May;287(2):667-675. doi: 10.1148/radiol.2017162610. Epub 2018 Jan 31.