An imaging study of 64Cu-SARTATE using positron emission tomography in patients with neuroendocrine tumours
- Conditions
- ow & Intermediate Grade Neuroendocrine TumorsLow & Intermediate Grade Neuroendocrine TumorsCancer - Neuroendocrine tumour (NET)
- Registration Number
- ACTRN12615000727549
- Lead Sponsor
- Clarity Pharmaceuticals PTY LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
1. Signed informed consent
2.Age greater than or equal to 18 years
3.Life expectancy greater than or equal to 8 weeks
4.Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)
5.At least one site of active somatostatin receptor positive malignancy, as demonstrated on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care
6.Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
1.Pregnant or breastfeeding females
2.Known sensitivity or allergy to somatostatin analogues
3.Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT & 64Cu-SARTATE PET/CT scan
4.Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
5.Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
6.QTc interval greater than 0.44seconds as measured by screening ECG
7.Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
8.Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Occurrence of adverse clinical, biochemical or haematological events following 64Cu-SARTATE administration as assessed using medical history and blood tests (composite outcome) at visit 2 and visit 3. <br>[At visit 2 (day 2) and visit 3 (day 8)<br><br>];Percentage of injected 64Cu-SARTATE dose found in organs of interest at 30mins, 1hr, 4hrs and 24hrs following administration of Investigational Product, via whole body PET scan[30mins, 1hr, 4hrs and 24hrs following administration ];Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome) <br>[30mins, 1hr, 4hrs and 24hrs following administration ]
- Secondary Outcome Measures
Name Time Method Whether 64Cu-SARTATE PET/CT scans demonstrate known sites of 68Ga-DOTATATE avid malignancy with equivalent or greater tumor to background ratios, where background uptake is that found in a non-tumor containing area of interest as decided upon by the nuclear medicine physician at the time of scan assessment.[30mins, 1hr, 4hrs and 24hrs following administration ];Whether 64Cu-SARTATE PET/CT scans demonstrate any non-physiological, non-tumor containing tissues with uptake greater than 1.5 x that of the background, where background uptake is defined as in secondary endpoint.[30mins, 1hr, 4hrs and 24hrs following administration ]