Clinical trial · Interventional
Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer
NCT02844647CI-TRIAL-00065088terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of participants
Summary
Brief summary (as posted)
A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with the new hyperpolarized MRI (1 hour exam) prior to treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized Pyruvate (13C) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI w/ Hyperpolarized Pyruvate (13C)
- description
- "Hyperpolarization" of low natural abundance species such as 13C, when injected offers the potential of extracting metabolic information by real-time MR imaging of biochemical reactions within the body. The biochemical reactions, including lactate production, will be measured using MRI.
- interventionNames
- Other: Hyperpolarized Pyruvate (13C)
Primary outcomes (1)
- measure
- Images of lactate, bicarbonate and pyruvate in patients with bone-metastatic CRPC measured by MRI
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men with bone-metastatic CRPC before starting the first dose of radium 223 therapy * Laboratory requirements: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelet count ≥ 100 x109/L * Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L) * Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN) * ASAT and ALAT ≤ 2.5 ULN * • Creatinine ≤ 1.5 ULN * Albumin \>25 g/L * Eastern Cooperative Oncology Group Status of 0 or 1 Exclusion Criteria: * Unable to give valid informed consent * Contraindication for MRI as per Sunnybrook MRI questionnaire (Appendix 1). * Claustrophobia * Body mass index of less than 18.5 or greater than 32 * Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year
References
Publications (0)
Data not yet available
No reference posted for this study.