A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)

Neuroendocrine Tumors Clinical Trial

Official title:

Positron Emission Tomography Imaging of Participants With Known or Suspected Neuroendocrine Tumours Using 64Cu SARTATE: A Multi-Centre, Single Arm, Non-Randomised, Blinded-Review, Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04438304
• Other study ID #: CLS07
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2, 2021
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Clarity Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 64Cu-SARTATE
64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Royal North Shore Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Clarity Pharmaceuticals Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings	Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 4 hours post administration of 64Cu-SARTATE
Primary	Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings	Sensitivity and Specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 20 hours post administration of 64Cu-SARTATE
Primary	Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings	Lesion detection rate on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 4 and 20 hours post administration of 64Cu-SARTATE
Primary	To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE	Concordance measured on a per-lesion basis	At 4 hours post administration of 64Cu-SARTATE
Secondary	To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.	Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.; Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 4 hours and 20 hours post administration of 64Cu-SARTATE
Secondary	Incidence of adverse events related to 64Cu-SARTATE	Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	1 week post administration of 64Cu-SARTATE