Neuroendocrine TumorsPhase 2NCT03278275
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
A Phase 2 study testing One injection of 68Ga-NOTA-AE105 and PET/CT in people with Neuroendocrine Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (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?
- One injection of 68Ga-NOTA-AE105 and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to 8 Jul 2021
- 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
- Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
- WHO performance status 0-2
- Must be able to read and understand the patient information in Danish and to give informed consent
Who cannot join
- Pregnancy
- Breast-feeding
- Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
- History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E[c(RGDyK)]2
- In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, 2100
About this study
The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).
Read the detailed description
68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)
- Conditions
- Neuroendocrine Tumors
- Being tested
- One injection of 68Ga-NOTA-AE105, PET/CT
- Keywords
- urokinase plasminogen activator receptor, uPAR PET/CT, positron emission tomography, neuroendocrine tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One injection of 68Ga-NOTA-AE105Drug
One injection of 68Ga-NORA-AE105
PET/CTDevice
Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT
| Study group | Role | What they receive |
|---|---|---|
| uPAR PET/CT | Experimental | One injection of the radioligand 68Ga-NOTA-AE105 Receives: Drug: One injection of 68Ga-NOTA-AE105; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
uPAR PET/CT imaging of patients with neuroendocrine tumors
The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)
Measured: 1 hour
Secondary outcomes (2)
uPAR PET/CT prognostic factor for progression free survival
The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)
Measured: 12 months
uPAR PET/CT prognostic factor for overall and disease specific survival
The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Nov 2017
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esben Carlsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Esben Carlsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278275
- Sponsor's protocol ID
- AK2017-1
- Other IDs
- 2017-002312-13, 2017
- Status last verified
- Jun 2022
- First submitted
- 8 Sep 2017
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
- ClinicalTrials.gov ID
- NCT03278275
- Acronym / sponsor ID
- AK2017-1
- Conditions
- Neuroendocrine Tumors
- Keywords
- urokinase plasminogen activator receptor, uPAR PET/CT, positron emission tomography, neuroendocrine tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 11 Sep 2017 (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 aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).
Detailed description
68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uPAR PET/CT | Experimental | Drug: One injection of 68Ga-NOTA-AE105, Device: PET/CTOne injection of the radioligand 68Ga-NOTA-AE105 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
- WHO performance status 0-2
- Must be able to read and understand the patient information in Danish and to give informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Breast-feeding
- Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
- History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E[c(RGDyK)]2
- In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
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 |
|---|---|---|
| One injection of 68Ga-NOTA-AE105One injection of 68Ga-NORA-AE105 | Drug | uPAR PET/CT |
| PET/CTFollowing injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT | Device | uPAR PET/CT |
Primary outcome
uPAR PET/CT imaging of patients with neuroendocrine tumors
Time frame: 1 hour
The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)
2 secondary outcomes
uPAR PET/CT prognostic factor for progression free survival
Time frame: 12 months
uPAR PET/CT prognostic factor for overall and disease specific survival
Time frame: 12 months
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 30 Jun 2022.
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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.
Esben Carlsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One injection of 68Ga-NOTA-AE105 and PET/CT in people with Neuroendocrine Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 5 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
uPAR PET/CT imaging of patients with neuroendocrine tumors (time frame: 1 hour). 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 30 Jun 2022.