Neuroendocrine Tumors
Conditions
Brief summary
The purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors (NETs) as a potential new way to help diagnose NETs.
Detailed description
Up to 63 participants will be recruited in this study and who are confirmed or suspected to have NETs based on biochemical evidence or that of conventional anatomical or molecular imaging.
Interventions
DRUG64Cu-SARTATE
64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.
Sponsors
Clarity Pharmaceuticals Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent; 2. Age at enrolment ≥ 18 years; 3. Life expectancy ≥ 12 weeks; 4. Known diagnosis of GEP NET or suspicion of GEP NET based on axial imaging (e.g. on CT and/or MRI and/or FDG) and/or biochemical evidence of NET; 5. Adequate recovery from acute toxic effects of any prior therapy; 6. Adequate renal function (eGFR \>30 ml/min); 7. Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;
Exclusion criteria
1. Female participant who are pregnant or lactating; 2. Male or female participant of childbearing potential not willing to practice an effective method of birth control while participating on the study to avoid possible damage to the foetus. Abstinence is considered acceptable; 3. Participant has received any treatment (including experimental treatment) for their NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan; 4. Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study; 5. History of other active malignancy within the last 2 years the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study). 6. Active oncologic therapy within 8 weeks prior to the 68GaDOTATATE PET/CT scan (long-acting somatostatin analogues are permitted and not considered active oncological treatment); 7. Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan; 8. Participants with extensive marrow/skeletal involvement (\>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings | At 4 hours post administration of 64Cu-SARTATE | Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT. |
| To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE | At 4 hours post administration of 64Cu-SARTATE | Concordance measured on a per-lesion basis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only. | At 4 hours and 20 hours post administration of 64Cu-SARTATE | 1. Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT. 2. Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT. |
| Incidence of adverse events related to 64Cu-SARTATE | 1 week post administration of 64Cu-SARTATE | Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
Countries
Australia
Outcome results
None listed