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Hyperpolarized Pyruvate Imaging for Cancer

N/A

Recruiting

Led By Kayvan Keshari, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Negative serum or urine pregnancy test for female patients of childbearing age and potential, from assays obtained < 2 weeks prior to study enrollment

Must not have

Inability or refusal to have at least one peripheral intravenous line for intravenous access on the day of [1-13C] pyruvate injection

Acute major illness (e.g., unstable cardiovascular condition, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new imaging agent can help doctors more accurately see how diseases like cancer are affecting a patient's organs.

Who is the study for?

This trial is for patients with certain cancers (sarcoma, prostate, breast, brain, metastatic or pancreatic) who can undergo MRI scans. They must not be pregnant or breastfeeding and should have a tumor that's measurable. People with severe liver or kidney issues, major illnesses like unstable heart conditions, or those who cannot tolerate an MRI due to devices like pacemakers are excluded.

What is being tested?

The study tests the reliability of hyperpolarized [1-13C] pyruvate (HP) in MRI scans for cancer patients by conducting two HP-MRI scans to see if they produce consistent results each time. It also compares these images with surgical pathology to check if it offers extra details on disease metabolism.

What are the potential side effects?

Since this trial focuses on imaging reproducibility using hyperpolarized Pyruvate in MRIs rather than drug effects, side effects are minimal but may include discomfort from lying still during the scan and potential reactions to the contrast agent used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured or seen on scans, with a tumor larger than 1cm.

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I am not pregnant, confirmed by a recent test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or will not have an IV line placed for a pyruvate injection.

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I do not have any severe illnesses like heart problems.

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My liver function tests are within normal limits.

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My kidney function is reduced with creatinine levels high or clearance low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

validate HP MRI at MSKCC (are the scans able to be reproduced)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hyperpolarized Pyruvate MRI ReproducibilityExperimental Treatment1 Intervention

This is a reproducibility study of hyperpolarized \[1-13C\] pyruvate MRI in patients with solid tumors. A total of 100 patients will be enrolled, 50 of whom will be imaged using 1D MR spectroscopy and the other 50 with 3D imaging sequence.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperpolarized Pyruvate

2017

Completed Phase 1

~10

0 / 6Eligibility criteria met