Clinical trial · Interventional
Simultaneous Hyperpolarized [1-13C]Pyruvate and 18F-FDG PET/MRS in Cancer Patients
Phase IIa Clinical Trial: Feasibility Study on Non-Invasive Simultaneous Hyperpolarized [1-13C]Pyruvate Magnetic Resonance Spectroscopy and 18F-FDG PET (hyperPET) for Metabolic Imaging in Patients With Cancer
NCT05396118CI-TRIAL-00077133unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective phase 2a clinical trial to demonstrate proof-of-concept for simultaneous hyperpolarized \[1-13C\]pyruvate and 18F-FDG for positron emission tomography (PET) and MRS (magnetic resonance spectroscopy) in a PET/MR scanner in patients with cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma Metastatic | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| Injection of hyperpolarized [1-13C]Pyruvate | Drug | — | UNRESOLVED |
| PET/MR/MRS/MRSI scanning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Injection of 18F-FDG and injections of hyperpolarized \[1-13C\]Pyruvate and subsequent PET/MRI/MRS scan
- interventionNames
- Drug: 18F-FDG
- Drug: Injection of hyperpolarized [1-13C]Pyruvate
- Procedure: PET/MR/MRS/MRSI scanning
Primary outcomes (5)
- measure
- Whole-tumor lactate/pyruvate ratio measured with MRS
- timeFrame
- Up to 10 minutes after injection of hyperpolarized [1-13C]Pyruvate
- description
- Whole-tumor lactate/pyruvate ratio measured with MRS in regions-of-interest covering the tumor lesion(s) following injection of hyperpolarized \[1-13C\]Pyruvate
- measure
- Whole-tumor glucose uptake measured with PET (static)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with breast cancer, gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) grades G1, G2 or G3, lymphoma or sarcoma * Measurable solid tumor of at least 1.5 cm * Capable of understanding the patient information in Danish and giving full informed consent Exclusion Criteria: * Pregnancy * Breast-feeding * Weighs above 140 kg and/or with abdominal circumference exceeding the gantry of the PET/MR coil (120 cm) * History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FDG or pyruvate * Patients who are unable to lie in the MR scanner for up to 90 minutes * Pace-maker * Metallic implantations within the past 6 weeks * Non-MR compatible implants * Claustrophobia * Participants who have not fasted for a minimum of 4 hours prior to the planned scan time
References
Publications (0)
Data not yet available
No reference posted for this study.