Head and Neck CancerPhase 2NCT02965001
Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
A Phase 2 study testing 68Ga-NOTA-AE105 in people with Head and Neck Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there has been made substantial improvements in diagnosis, staging and treatment of HNC. The overall survival has improved, but for some subgroups it is unchanged and therefore new prognostic and surveillance methods are warranted. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 68Ga-NOTA-AE105
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has a diagnosis of biopsy-verified cancer of the pharynx, larynx or oral cavity
- is referred to curative intended radiotherapy
- understands the given information and has given informed consent and
- age above 18 years.
Who cannot join
- Pregnancy, lactation/breast feeding, age above 85 years, obesity (bodyweight above 140 kg), small cancers of the larynx (1A,1B), allergy to 68Ga-NOTA-AE105, metastasis on FDG-PET/CT, other previously known cancers, claustrophobia.
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departmen of Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
About this study
Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there has been made substantial improvements in diagnosis, staging and treatment of HNC. The overall survival has improved, but for some subgroups it is unchanged and therefore new prognostic and surveillance methods are warranted.
One of the hallmarks in cancer is the ability to invade the surrounding tissue and metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA) and its receptor (uPAR) are present at the very front of the invasive tumor and they are considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer offers a very promising target for functional PET imaging and may be a stronger prognostic marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx and oral cavity, who are referred to curative intended radiotherapy. In this project all participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy and the prognostic efficacy is determined by assessment of the recurrence rate and mortality at routine clinical follow-up.
Read the detailed description
In this study all included patients with head and neck cancer (HNC) have an uPAR-PET/CT scan performed before the initiation of the curative intended radiotherapy. After the radiotherapy treatment the patients attend the routine clinical follow-up programme at Rigshospitalet to follow the loco-regional control, signs of metastasis and the overall survival. These relapse- and survival parameters will be correlated to the SUVmax, SUVmean and the TNM stage obtained from the uPAR scan and will be compared to the findings on the routine FDG scan to clarify which tracer is the strongest prognostic marker in HNC.
If any previous tissue samples have been taken from the tumour before the patient enters the study the uPAR immunohistopathology of the tissue sample will be compared to the uPAR-PET/CT findings. We will not perform any biopsies or tissue samples in this study.
- Conditions
- Head and Neck Cancer
- Being tested
- 68Ga-NOTA-AE105
- Keywords
- Molecular Imaging, uPAR-PET/CT, Head and neck cancer, curative intended radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-AE105Drug
Also called uPAR
The patients are refered to an uPAR-PET/CT scan before initiation of the routine radiotherapy and the prognostic efficacy is assessed by registration of recurrence rate and death at routine clinical follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-AE105 | Experimental | All participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy Receives: Drug: 68Ga-NOTA-AE105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any failure
Measured: 1-3 years
Secondary outcomes (4)
Overall Survival
Measured: 1-3 years
Disease free survival
Measured: 1-3 years
Distant metastasis free survival
Measured: 1-3 years
Loco-regional control
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Madeleine Risør, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Kjær, Professor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965001
- Sponsor's protocol ID
- 366_16
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Risor LM, Clausen MM, Ujmajuridze Z, Farhadi M, Andersen KF, Loft A, Friborg J, Kjaer A. Prognostic Value of Urokinase-Type Plasminogen Activator Receptor PET/CT in Head and Neck Squamous Cell Carcinomas and Comparison with 18F-FDG PET/CT: A Single-Center Prospective Study. J Nucl Med. 2022 Aug;63(8):1169-1176. doi: 10.2967/jnumed.121.262866. Epub 2021 Dec 2.
PubMed 34857658
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
- ClinicalTrials.gov ID
- NCT02965001
- Acronym / sponsor ID
- 366_16
- Conditions
- Head and Neck Cancer
- Keywords
- Molecular Imaging, uPAR-PET/CT, Head and neck cancer, curative intended radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 16 Nov 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.
Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there has been made substantial improvements in diagnosis, staging and treatment of HNC. The overall survival has improved, but for some subgroups it is unchanged and therefore new prognostic and surveillance methods are warranted.
One of the hallmarks in cancer is the ability to invade the surrounding tissue and metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA) and its receptor (uPAR) are present at the very front of the invasive tumor and they are considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer offers a very promising target for functional PET imaging and may be a stronger prognostic marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx and oral cavity, who are referred to curative intended radiotherapy. In this project all participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy and the prognostic efficacy is determined by assessment of the recurrence rate and mortality at routine clinical follow-up.
Detailed description
In this study all included patients with head and neck cancer (HNC) have an uPAR-PET/CT scan performed before the initiation of the curative intended radiotherapy. After the radiotherapy treatment the patients attend the routine clinical follow-up programme at Rigshospitalet to follow the loco-regional control, signs of metastasis and the overall survival. These relapse- and survival parameters will be correlated to the SUVmax, SUVmean and the TNM stage obtained from the uPAR scan and will be compared to the findings on the routine FDG scan to clarify which tracer is the strongest prognostic marker in HNC.
If any previous tissue samples have been taken from the tumour before the patient enters the study the uPAR immunohistopathology of the tissue sample will be compared to the uPAR-PET/CT findings. We will not perform any biopsies or tissue samples in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-AE105 | Experimental | Drug: 68Ga-NOTA-AE105All participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- has a diagnosis of biopsy-verified cancer of the pharynx, larynx or oral cavity
- is referred to curative intended radiotherapy
- understands the given information and has given informed consent and
- age above 18 years.
Key exclusion criteria (2 listed)
- Pregnancy, lactation/breast feeding, age above 85 years, obesity (bodyweight above 140 kg), small cancers of the larynx (1A,1B), allergy to 68Ga-NOTA-AE105, metastasis on FDG-PET/CT, other previously known cancers, claustrophobia.
- -
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-AE105Also: uPARThe patients are refered to an uPAR-PET/CT scan before initiation of the routine radiotherapy and the prognostic efficacy is assessed by registration of recurrence rate and death at routine clinical follow-up. | Drug | 68Ga-NOTA-AE105 |
Primary outcome
Freedom from any failure
Time frame: 1-3 years
4 secondary outcomes
Overall Survival
Time frame: 1-3 years
Disease free survival
Time frame: 1-3 years
Distant metastasis free survival
Time frame: 1-3 years
Loco-regional control
Time frame: 1-3 years
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 3 Nov 2022.
- Derived from this study: PubMed 34857658Risor LM, Clausen MM, Ujmajuridze Z, Farhadi M, Andersen KF, Loft A, Friborg J, Kjaer A. Prognostic Value of Urokinase-Type Plasminogen Activator Receptor PET/CT in Head and Neck Squamous Cell Carcinomas and Comparison with 18F-FDG PET/CT: A Single-Center Prospective Study. J Nucl Med. 2022 Aug;63(8):1169-1176. doi: 10.2967/jnumed.121.262866. Epub 2021 Dec 2.
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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.
Andreas Kjær, Professor study director
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 68Ga-NOTA-AE105 in people with Head and Neck Cancer, 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 4 inclusion and 2 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 3 Nov 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?
Freedom from any failure (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965001, which also lists 1 linked publication.
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 3 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.