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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NOTA-AE105 | Experimental | All participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-AE105 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any failure | 1-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 1-3 years | |
| Disease free survival | 1-3 years | |
| Distant metastasis free survival |
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Inclusion Criteria:The patient
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Kjær, Professor | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departmen of Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34857658 | Derived | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 1-3 years |
| Loco-regional control | 1-3 years |