None listed
Conditions
Brief summary
68Ga NODAGA GSAO is a new radioactive compound that when injected allows a different type of PET scan to be performed to directly image dead and dying cells. This study aims to determine how 68Ga GSAO is taken up by both cancer and non-cancer cells in a small group of cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a histologically or cytologically confirmed solid cancer with at least one measurable lesion >2 cm and you meet pre-specified requirements for liver and renal function. Please note that patients with primary or metastatic brain or spinal cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will be injected with 68Ga NODAGA GSAO and following this they will undergo a total of eight PET imaging scans (during which they will be required to lie still on a scanning bed breathing normally). The first six scans will be performed one after the other (total duration of approximately 90 minutes). Participants will then have a break and then undergo two further scans each taking approximately 30 to 40 minutes (with a break in between). Participants will also have blood and urine samples collected to determine the amount of 68Ga NODAGA GSAO in blood and excreted in urine. The total duration of the study will be approximately five hours. Patients will also be followed up for 7 days after 68Ga NODAGA GSAO PET scanning to determine if they have experienced any side effects from the injection. It is hoped this research may be used to improve health outcomes for future cancer patients by investigating the safety and usefulness of the 68Ga NODAGA GSAO PET scan to image cancer cell death as a way of determining cancer treatment response earlier and more accurately than currently available imaging methods.
Interventions
Participants will receive one intravenous injection of 200Mbq of [68Ga]gallium 2,2'-(7-(4-((1-carboxy-4-((1-((carboxymethyl)amino)-3-((2-((4-(dihydroxyarsaneyl)phenyl)amino)-2-oxoethyl)thio)-1-oxopropan-2-yl)amino)-4-oxobutyl)amino)-1-carboxylato-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetate (68Ga NODAGA GSAO). This will be administered by a nuclear medicine specialist or medical radiation scientist.
Following this participants will undergo a total of eight PET scans (during which they will
Participants will receive one intravenous injection of 200Mbq of [68Ga]gallium 2,2'-(7-(4-((1-carboxy-4-((1-((carboxymethyl)amino)-3-((2-((4-(dihydroxyarsaneyl)phenyl)amino)-2-oxoethyl)thio)-1-oxopropan-2-yl)amino)-4-oxobutyl)amino)-1-carboxylato-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetate (68Ga NODAGA GSAO). This will be administered by a nuclear medicine specialist or medical radiation scientist. Following this participants will undergo a total of eight PET scans (during which they will be required to lie still on a scanning bed breathing normally). The first six scans will be performed one after the other commencing at 0, 7, 17, 29, 47 and 65 minutes after 68Ga NODAGA GSAO administration (total duration of approximately 90 minutes). The participant will then have a break and then undergo two further scans commencing at 120 and 180 minutes after 68Ga NODAGA GSAO administration each taking approximately 30 to 40 minutes (with a break in between). Participants will also have also have blood and urine samples collected to determine the amount of 68Ga NODAGA GSAO in blood and excreted in urine. The total duration of the study will be approximately five hours.
Sponsors
Prince of Wales Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must be able to understand and willing to sign the written informed consent Male or female patients greater than or equal to 18 years of age Histologically or cytologically confirmed solid malignancy with at least one measurable lesion greater than 2 cm Adequate liver function (bilirubin less than or equal to 1.5 upper limit normal (ULN), ALT and AST less than or equal to 4 ULN) Adequate renal function (eGFR greater than less than or equal to 50 ml/min/1.73m2) Adequate bone marrow function (absolute neutrophil count greater than or equal to 1.5 x 10^9/l, haemoglobin level greater than or equal to 9.0 g/dl and platelets greater than or equal to 100 ×x 10^9/l). Serum potassium greater than or equal to 3.0mmol/l and magnesium greater than or equal to 0.6mmol/l
Exclusion criteria
Cancer treatment within the previous 6 weeks Primary or isolated metastatic CNS malignancy Active uncontrolled infection Congestive heart failure or prior NYHA class III-IV cardiac disease Uncontrolled hypertension (systolic BP > 180mmHg or diastolic BP >100mmHg) Evidence of recent heart disease (myocardial infarction in the past 2 months by ECG, arrhythmias associated with QTc prolongation or evidence of ischemia) Evidence of QTc > 480 ms Medications that prolong QTc Pregnancy Breast feeding
Outcome results
None listed