Cancer Cancer
Conditions
Interventions
This is a non-randomised, first-in-human physiological imaging study with a study design that will be conducted in two stages which may run in parallel:
Stage 1 - Injection of 13C-fumarate into health
Stage 2 - Dynamic 13C-MRI in patients to optimise the MRI technique in malignant tissue.
This is a physiological study and will not change the treatment that has been determined for the patients eithe
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All participants: 1. Over 18 years old 2. Able to and provide written informed consent to participate 3. If female, postmenopausal or if women of childbearing potential (WOCBP) using a suitable contraception 4. If male, using a suitable contraceptive method for the duration of the study Healthy volunteers (Stage 1): Not on any regular medications (except the oral contraceptive pill) that may impact the study results as determined by the researcher Cancer patients (Stage 2): 1. Radiologically evaluable disease as established by clinical imaging 2. Capable of undergoing repeat study visits
Exclusion criteria
Exclusion criteria: The presence of any of the following will preclude participation as determined by the delegated investigator: 1. Contraindication or inability to tolerate MRI 2. Pregnant or actively breast-feeding woman 3. If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI-safe at 3 T (researcher to confirm) 4. Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators 5. Laboratory abnormalities that may impact the study results 6. Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI signal of hyperpolarised 13C-fumarate and its metabolite 13C-malate measured using dynamic MRI to study fumarate metabolism in normal tissue and in tumours at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Optimal dose of injected hyperpolarised 13C-fumarate to enable the detection of hyperpolarised 13C-malate formation in tumours measured using dynamic MRI at one timepoint 2. Optimise 13C-MRI parameters to provide the optimal hyperpolarised 13C-fumarate and 13C-malate signal-to-noise ratios (SNR) measured using dynamic MRI at one timepoint 3. Correlations between serum fumarate, serum malate, fumarate hydratase (FH) and the MR signal acquired from the dynamic 13C-malate/13C-fumarate MRI data at one timepoint 4. Correlations between tissue expression (archival or fresh tissue) of metabolic and other markers (such as FH) and the MR signal acquired from the dynamic 13C malate/13C fumarate MRI data at one timepoint | — |
Countries
England, United Kingdom
Outcome results
None listed