Neuroendocrine TumorsPhase 2NCT04438304
A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)
A Phase 2 study testing 64Cu-SARTATE in people with Neuroendocrine Tumors, run by Clarity Pharmaceuticals Ltd at 4 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 64Cu-SARTATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesAustralia
- Study dates
- 2 Mar 2021to 26 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Age at enrolment ≥ 18 years;
- Life expectancy ≥ 12 weeks;
- 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;
- Adequate recovery from acute toxic effects of any prior therapy;
- Adequate renal function (eGFR >30 ml/min);
- Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;
Who cannot join
- Female participant who are pregnant or lactating;
- 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;
- 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;
- Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
- 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).
- 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);
- Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan;
- Participants with extensive marrow/skeletal involvement (>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Nepean Hospital
Kingswood, New South Wales, 2751
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Royal North Shore Hospital
Sydney, New South Wales, 2065
About this study
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
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.
Read the 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 64Cu-SARTATE
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-SARTATEDrug
Also called 64Cu-MeCOSar-Octreotate
64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection. Receives: Drug: 64Cu-SARTATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 4 hours post administration of 64Cu-SARTATE
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.
Measured: At 20 hours post administration of 64Cu-SARTATE
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.
Measured: At 4 and 20 hours post administration of 64Cu-SARTATE
To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE
Concordance measured on a per-lesion basis
Measured: At 4 hours post administration of 64Cu-SARTATE
Secondary outcomes (2)
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.
Measured: At 4 hours and 20 hours post administration of 64Cu-SARTATE
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.
Measured: 1 week post administration of 64Cu-SARTATE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start2 Mar 2021
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438304
- Sponsor's protocol ID
- CLS07
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04438304
- Acronym / sponsor ID
- CLS07
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: 64Cu-SARTATE64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Age at enrolment ≥ 18 years;
- Life expectancy ≥ 12 weeks;
- 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;
- Adequate recovery from acute toxic effects of any prior therapy;
Key exclusion criteria (8 listed)
- Female participant who are pregnant or lactating;
- 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;
- 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;
- Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-SARTATEAlso: 64Cu-MeCOSar-Octreotate64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg. | Drug | Intervention |
Primary outcome
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
Time frame: 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.
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
Time frame: At 20 hours post administration of 64Cu-SARTATE
Sensitivity and Specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
Time frame: At 4 and 20 hours post administration of 64Cu-SARTATE
Lesion detection rate on composite of 4-hour and 20-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
Time frame: At 4 hours post administration of 64Cu-SARTATE
Concordance measured on a per-lesion basis
2 secondary outcomes
To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.
Time frame: At 4 hours and 20 hours post administration of 64Cu-SARTATE
Incidence of adverse events related to 64Cu-SARTATE
Time frame: 1 week post administration of 64Cu-SARTATE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 64Cu-SARTATE in people with Neuroendocrine Tumors, run by Clarity Pharmaceuticals Ltd at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings (time frame: At 4 hours post administration of 64Cu-SARTATE). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.