Non-small Cell Lung CancerPhase 2NCT02755675
uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung
A Phase 2 study testing 68Ga-NOTA-AE105 PET/CT in people with Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
uPAR PET/CT as a prognostic marker in non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma, Large Cell Neuroendocrine Carcinoma of the Lung
- What is being tested?
- 68Ga-NOTA-AE105 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to Oct 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study I
- Histologically verified NSCLC (Study I)
- Stage IV disease
- Operable disease
- The participants must be capable of understanding and giving full informed written consent
- Study II
Show all 11Show fewer
- Histologically verified MPM (Study II)
- The participants must be capable of understanding and giving full informed written consent
- Study III
- Histologically verified LCNEC (Study III)
- The participants must be capable of understanding and giving full informed written consent
Who cannot join
- Study I, II, III
- Pregnancy
- Lactation/breast feeding
- Treatment with neoadjuvant chemotherapy
- Weight above 140 kg
- Allergy to 68Ga-NOTA-AE105
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, 2100
Malene M Clausen, MD, PhD, +4522524536, malene.martini.clausen@regionh.dk
Andreas Kjaer, Professor, MD, DMSc, PhD, +4535454011, akjaer@sund.ku.dk
About this study
uPAR PET/CT as a prognostic marker in non-small cell lung cancer.
Read the detailed description
Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.
Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.
- Conditions
- Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma, Large Cell Neuroendocrine Carcinoma of the Lung
- Being tested
- 68Ga-NOTA-AE105 PET/CT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-AE105 PET/CTOther
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-AE105 PET/CT | Experimental | One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before treatment start to evaluate the prognostic value of uPAR PET/CT. Receives: Other: 68Ga-NOTA-AE105 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Ia: Overall survival (OS)
Measured: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Overall survival (OS)
Measured: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)
Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-)
Measured: Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105
Secondary outcomes (2)
Study Ia: Progression free survival (PFS)
Measured: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Disease free survival (DFS)
Measured: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Martini Clausen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755675
- Sponsor's protocol ID
- AK-2015-LC-1
- Status last verified
- Nov 2016
- First submitted
- 19 Apr 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT02755675
- Acronym / sponsor ID
- AK-2015-LC-1
- Conditions
- Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma, Large Cell Neuroendocrine Carcinoma of the Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
uPAR PET/CT as a prognostic marker in non-small cell lung cancer.
Detailed description
Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR.
Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-AE105 PET/CT | Experimental | Other: 68Ga-NOTA-AE105 PET/CTOne injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before treatment start to evaluate the prognostic value of uPAR PET/CT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Study I
- Histologically verified NSCLC (Study I)
- Stage IV disease
- Operable disease
- The participants must be capable of understanding and giving full informed written consent
Key exclusion criteria (6 listed)
- Study I, II, III
- Pregnancy
- Lactation/breast feeding
- Treatment with neoadjuvant chemotherapy
- Weight above 140 kg
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 |
|---|---|---|
| 68Ga-NOTA-AE105 PET/CTFollowing injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT | Other | 68Ga-NOTA-AE105 PET/CT |
Primary outcome
Study Ia: Overall survival (OS)
Time frame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Overall survival (OS)
Time frame: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)
Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-)
Time frame: Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105
2 secondary outcomes
Study Ia: Progression free survival (PFS)
Time frame: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)
Study Ib: Disease free survival (DFS)
Time frame: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: No
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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.
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 68Ga-NOTA-AE105 PET/CT in people with Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma, 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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malene M Clausen, MD, PhD (+4522524536, malene.martini.clausen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Ia: Overall survival (OS) (time frame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)). The study lists 3 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 21 Nov 2016.