Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02965001|
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: 68Ga-NOTA-AE105||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
All participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy
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.
Other Name: uPAR
- Freedom from any failure [ Time Frame: 1-3 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965001
|Contact: Louise Madeleine Risør, MD||29896610 ext email@example.com|
|Contact: Andreas Kjær, Professor||35455011 ext firstname.lastname@example.org|
|Departmen of Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Louise Madeleine Risør, MD 29896610 email@example.com|
|Study Director:||Andreas Kjær, Professor||Rigshospitalet, Denmark|