Schedule of assessments
Assessment | Visit/days | |||
Screening† | Baseline MRI visit | Optional repeat MRI visit within 7 days of baseline (if applicable) | Optional MRI visit with different imaging technique within 14 days of baseline (if applicable) | |
Attend unit | * | * | * | * |
Consent‡ | * | * | * | * |
Medical history | * | |||
Demography (weight, height, sex, date of birth) | * | |||
Clinical examination | * | |||
ECOG performance score | * | * if clinically indicated | * if clinically indicated | * if clinically indicated |
Venous blood sample§¶ | * | * | * | * |
Pregnancy test in WOCBP | * | * | * | * |
MRI scan | * | * | * | |
General/additional assessments | * if clinically indicated | * if clinically indicated | * if clinically indicated | |
Vital signs | ||||
Pre imaging | * | * | * | |
Post imaging | * | * | * | |
Injection of 13C-pyruvate and/or deuterated glucose drink (for 13C-pyruvate and DMI techniques only) | * | * | * |
*Applicable assessment.
†We will attempt to screen for participants during their standard of care visits and use of medical records.
‡Ongoing consent will be confirmed at each visit.
§Venous blood samples will include, but may not be limited to; biochemical series and liver function test.
¶Full blood count samples will only be required at injection timepoints if they have not been taken recently, that is, within 14 days. These results will be copied in the study data.
DMI, deuterium metabolic imaging; ECOG, Eastern Cooperative Oncology Group; WOCBP, woman of childbearing potential.