A Phase I/II Study of Hyperpolarized 13C Pyruvate as a Biomarker of Aggressiveness & Response to Therapy in Patients With Advanced Solid Tumors

22924

This is a single center prospective imaging study investigating the utility of hyperpolarized 13C-pyruvate/metabolic MR imaging. The current protocol will serve as a companion imaging biomarker study paired with standard of care (SOC) therapeutics, as well as investigational therapies that participants may be scheduled to receive outside of this protocol.

2022-12-15

2026-01-31

2026-01-31

Recruiting

Early phase I

65

Inclusion Criteria: 1. Presence of at least one target pelvic, abdominal, thoracic, neck or extremity lesion detected by standard staging scans that, in the judgment of study investigator, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging: a. Target lesion must measure at least 1.0 cm in long axis diameter on Computerized tomography (CT) or magnetic resonance imaging (MRI). 2. The participant is able and willing to comply with study procedures and provide signed and dated informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Adequate renal function defined as creatinine \< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \>50 mL/min (by the Cockcroft Gault equation). 5. Participants age 18 and older. Part B only: 6. Planned treatment for disease with either standard of care regimen or an investigational agent. Exclusion Criteria: 1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent. 2. Patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. 3. Patients with a metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging. 4. Patients with poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160mm Hg or diastolic blood pressure greater than 100mm Hg. Note: The addition of anti-hypertensives to control blood pressure is allowed. 5. Patients with congestive heart failure or New York Heart Association (NYHA) status \>= 2. 6. Patients who are pregnant or lactating. 7. A history of clinically significant EKG abnormalities or myocardial infarction (MI) within 6 months of study entry. Note: Patients with rate-controlled atrial fibrillation/flutter will be allowed on study. 8. Any condition that, in the opinion of the Principal Investigator,

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 65, 'type': 'ESTIMATED'}}

2023-12-20