Clinical trial NCT04440956: An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
Official title: Positron Emission Tomography (PET) Imaging of Patients With Low & Intermediate Grade Neuroendocrine Tumors Using 64Cu-SARTATE: A Single Centre, Open-Label, Non-Randomized, Phase-0 Microdosing Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neuroendocrine Tumors
Lead sponsor: Clarity Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of adverse events related to 64Cu-SARTATE
timeFrame: 1 week post administration
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
timeFrame: At 30 minutes following administration
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
timeFrame: At 1 hour following administration
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
timeFrame: At 4 hours following administration
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
timeFrame: At 24 hours following administration
measure: Absorbed organ dose
timeFrame: At 30 minutes following administration
measure: Absorbed organ dose
timeFrame: At 1 hour following administration
measure: Absorbed organ dose
timeFrame: At 4 hours following administration
measure: Absorbed organ dose
timeFrame: At 24 hours following administration
Secondary outcomes:
measure: Demonstration of known malignancy
timeFrame: 30 minutes, 1 hour, 4 hours and 24 hours following administration
measure: Uptake in non-physiological, non-tumor containing tissues
timeFrame: 30 minutes, 1 hour, 4 hours and 24 hours following administration
Other outcomes:
Locations:
Study officials:
References: