An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours

Neuroendocrine Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440956
• Other study ID #: CL01
• Status: Completed
• Phase: Early Phase 1
• Start date: May 21, 2015
• Est. completion date: February 25, 2016

Study information

• Verified date: June 2020
• Source: Clarity Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 25, 2016
• Est. primary completion date: February 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 64Cu-SARTATE
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clarity Pharmaceuticals Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events related to 64Cu-SARTATE	Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.	1 week post administration
Primary	Percentage of injected 64Cu-SARTATE dose found in organs of interest	Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan	At 30 minutes following administration
Primary	Percentage of injected 64Cu-SARTATE dose found in organs of interest	Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan	At 1 hour following administration
Primary	Percentage of injected 64Cu-SARTATE dose found in organs of interest	Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan	At 4 hours following administration
Primary	Percentage of injected 64Cu-SARTATE dose found in organs of interest	Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan	At 24 hours following administration
Primary	Absorbed organ dose	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)	At 30 minutes following administration
Primary	Absorbed organ dose	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)	At 1 hour following administration
Primary	Absorbed organ dose	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)	At 4 hours following administration
Primary	Absorbed organ dose	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)	At 24 hours following administration
Secondary	Demonstration of known malignancy	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.	30 minutes, 1 hour, 4 hours and 24 hours following administration
Secondary	Uptake in non-physiological, non-tumor containing tissues	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.	30 minutes, 1 hour, 4 hours and 24 hours following administration