An imaging study investigating a new magnetic resonance imaging tracer for cancer detection and cancer treatment monitoring
- Conditions
- Cancer
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>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<br>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<br>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<br>