A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 90 |
| Updated: | 8/19/2018 |
| Start Date: | September 2012 |
| End Date: | September 2019 |
| Contact: | Mark Dunphy, D.O. |
| Phone: | 212-639-8131 |
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.
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.
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.)
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Mark Dunphy, DO
Phone: 212-639-8131
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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