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New treatment option for Malignant Solid Tumors
Official title Characterization of Hyperpolarized Pyruvate MRI Reproducibility
ClinicalTrials.gov ID: NCT02421380
What this study is testing
What is Hyperpolarized Pyruvate?
Hyperpolarized Pyruvate is an investigational medicine, being studied as a potential treatment for malignant solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to test a new approach to see if the test results can be reproduced each time the Magnetic resonance imaging (MRI) is done for an individual patient. The study will explore the use of an imaging agent called hyperpolarized [1-13C] pyruvate (HP) with MRI scans.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 90
You may be able to join if
- Patients with history of histologically-confirmed malignant solid tumor (histology confirmed by MSKCC Department of Pathology.) NOTE: An exception...
- Disease measurable or evaluable as defined by RECIST 1.1, a mass of greater than 1cm in the long axis and/or other tumor response criteria from an...
- Negative serum or urine pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from...
- This study will include only patients with sarcoma, prostate, breast, brain, metastatic or pancreatic cancer. In the future other patient groups may...
You likely can't join if
- Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [1-13C] pyruvate injection)
- Breast-feeding
- Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
- Hepatic: from assays obtained within 3-4 weeks prior to study enrollment. For each patient, the upper limit of normal (ULN) value for a particular...
- Bilirubin \> 1.5 x (ULN)
- AST/ALT \>2.5 x ULN
See the full eligibility criteria
- Patients with history of histologically-confirmed malignant solid tumor (histology confirmed by MSKCC Department of Pathology.) NOTE: An exception will be made for patients with brain lesions. Patients identified by a...
- Disease measurable or evaluable as defined by RECIST 1.1, a mass of greater than 1cm in the long axis and/or other tumor response criteria from an MSKCC IRB-approved clinical research protocol. NOTE: Study patients do...
- Negative serum or urine 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.
- This study will include only patients with sarcoma, prostate, breast, brain, metastatic or pancreatic cancer. In the future other patient groups may be included through amendment of this protocol.
- Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [1-13C] pyruvate injection)
- Breast-feeding
- Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
- Hepatic: from assays obtained within 3-4 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...
- 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 within 3-4 weeks prior to study enrollment
- Acute major illness (e.g., unstable cardiovascular condition, etc.)
- Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Montvale, New Jersey, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montvale, New Jersey, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.