Neuroendocrine TumorsEarly Phase 1NCT04440956
An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
A Early Phase 1 study testing 64Cu-SARTATE in people with Neuroendocrine Tumors, run by Clarity Pharmaceuticals Ltd.
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. 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
- 10 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2015to 25 Feb 2016
- Phase
- Early Phase 1
- 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 greater than or equal to 18 years
- Life expectancy greater than or equal to 8 weeks
- Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)
- 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
- Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
Who cannot join
- Pregnant or breastfeeding females
- Known sensitivity or allergy to somatostatin analogues
- Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT \& 64Cu-SARTATE PET/CT scan
- Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
- Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
- QTc interval greater than 0.44seconds as measured by screening ECG
- Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
About this study
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
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.
- 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
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") 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.
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.
Measured: 1 week post administration
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
Measured: At 30 minutes following administration
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
Measured: At 1 hour following administration
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
Measured: At 4 hours following administration
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
Measured: At 24 hours following administration
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)
Measured: At 30 minutes following administration
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)
Measured: At 1 hour following administration
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)
Measured: At 4 hours following administration
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)
Measured: At 24 hours following administration
Secondary outcomes (2)
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.
Measured: 30 minutes, 1 hour, 4 hours and 24 hours following administration
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.
Measured: 30 minutes, 1 hour, 4 hours and 24 hours following administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start21 May 2015
- Primary completion25 Feb 2016
- Study completion25 Feb 2016
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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT04440956
- Sponsor's protocol ID
- CL01
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04440956
- Acronym / sponsor ID
- CL01
- Conditions
- Neuroendocrine Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 25 Feb 2016 (actual)
- First posted
- 22 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 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.
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-SARTATE200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") 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 greater than or equal to 18 years
- Life expectancy greater than or equal to 8 weeks
- Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)
- 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
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding females
- Known sensitivity or allergy to somatostatin analogues
- Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT \& 64Cu-SARTATE PET/CT scan
- Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
- Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
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-Octreotate200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms. | Drug | Intervention |
Primary outcome
Incidence of adverse events related to 64Cu-SARTATE
Time frame: 1 week post administration
Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.
Percentage of injected 64Cu-SARTATE dose found in organs of interest
Time frame: At 30 minutes following administration
Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
Percentage of injected 64Cu-SARTATE dose found in organs of interest
Time frame: At 1 hour following administration
Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
Percentage of injected 64Cu-SARTATE dose found in organs of interest
Time frame: At 4 hours following administration
Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
Percentage of injected 64Cu-SARTATE dose found in organs of interest
Time frame: At 24 hours following administration
Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
Absorbed organ dose
Time frame: At 30 minutes following administration
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)
Absorbed organ dose
Time frame: At 1 hour following administration
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)
Absorbed organ dose
Time frame: At 4 hours following administration
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)
Absorbed organ dose
Time frame: At 24 hours following administration
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)
2 secondary outcomes
Demonstration of known malignancy
Time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration
Uptake in non-physiological, non-tumor containing tissues
Time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration
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 22 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Neuroendocrine Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 64Cu-SARTATE in people with Neuroendocrine Tumors, run by Clarity Pharmaceuticals Ltd.
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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of adverse events related to 64Cu-SARTATE (time frame: 1 week post administration). The study lists 9 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 22 Jun 2020.