Clinical trial · Interventional
Hyperpolarized C-13 Pyruvate as a Biomarker in Patients With Advanced Solid Tumor Malignancies
Hyperpolarized C-13 Pyruvate as a Biomarker of PI3K/mTOR Pathway Inhibition in Patients With Advanced Solid Tumor Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
This is a single center prospective imaging study investigating the utility of hyperpolarized C-13 pyruvate as a Biomarker of PI3K/mTOR pathway inhibition in patients with advanced solid tumor malignancies. The current protocol will serve as a companion imaging biomarker study paired with therapeutic trials of PI3K/mTOR pathway inhibitors (e.g. CUDC-907, BYL719), as well as a stand-alone protocol for patients treated with standard-of-care therapies inhibiting the PI3K/mTOR signaling pathway (eg. everolimus).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
| Pyruvate (13C) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Feasibility Run-In
- description
- Patients with advanced solid tumor malignancies with at least one liver metastasis will be enrolled with iterative adjustment of coil design to optimize imaging parameters including spatial resolution and signal-to-noise ratio (SNR) of hyperpolarized pyruvate / lactate within the target metastatic lesion(s).
- interventionNames
- Drug: Pyruvate (13C)
- Device: MRI
- type
- EXPERIMENTAL
- label
- Part B: Biomarker Cohort
- description
- Patients with advanced solid tumor malignancies and the presence of at least one liver metastasis amenable to hyperpolarized C-13 pyruvate metabolic MR imaging who are planning on being treated with agent targeting PI3K/mTOR pathway will be enrolled.
- interventionNames
- Drug: Pyruvate (13C)
- Device: MRI
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presence of at least one target liver or other intra-abdominal lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging: Target lesion must measure \>=1.0 cm in long axis diameter on CT or MRI * The subject is able and willing to comply with study procedures and provide signed and dated informed consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function, including creatinine \< 1.5 x ULN or estimated creatinine clearance \>=500 mL/min (by the Cockcroft Gault equation) and total bilirubin \<3x upper limit of normal (ULN). Part B only: * No prior local therapy to target lesion. * If patient agrees to optional biopsy: * Presence of at least one target lesion amenable to percutaneous tumor biopsy in the judgment of Interventional Radiology * No history of bleeding diathesis. * Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy. * Planned treatment with agent targeting PI3K/mTOR pathway (either standard of care or investigational agent) Exclusion Criteria: * Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent. * Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. * Metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging. * Poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg. The addition of anti-hypertensives to control blood pressure is allowed. * Congestive heart failure or New York Heart Association (NYHA) status ≥ 2. * A history of clinically significant EKG abnormalities, including QT prolongation (QTcF \> 500 ms), a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter will be allowed on study. * Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
References
Publications (0)
Data not yet available