Using a new imaging agent to detect tumors in cancer patients
A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)
This study is testing a new imaging agent to see if it can help find tumors more accurately in cancer patients compared to regular imaging methods.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT01697930 on ClinicalTrials.gov |
What this trial studies
This Phase I study investigates the use of a novel imaging agent, [18F] 4-L-Fluoroglutamine, in patients with solid malignancies and lymphoma. The study aims to determine how long the agent remains in the bloodstream and its distribution in the body after injection. By utilizing PET imaging, researchers hope to identify tumor locations more effectively than with standard imaging techniques. This is the first time this experimental drug is being tested in humans, following promising results in animal studies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21-90 with a confirmed diagnosis of solid malignancy or lymphoma.
Not a fit: Patients who are unable or unwilling to have intravenous access for the injection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of tumor detection in cancer patients, leading to better treatment outcomes.
How similar studies have performed: While this approach is novel in humans, previous studies in animals have shown promising results with similar imaging agents.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mark Dunphy, D.O. — Memorial Sloan Kettering Cancer Center
- Study coordinator: Mark Dunphy, D.O.
- Phone: 212-639-8131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.