Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
NCT number | NCT02965001 |
Other study ID # | 366_16 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | December 2021 |
Verified date | November 2022 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria:The patient - 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. 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. - |
Country | Name | City | State |
---|---|---|---|
Denmark | Departmen of Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from any failure | 1-3 years | ||
Secondary | Overall Survival | 1-3 years | ||
Secondary | Disease free survival | 1-3 years | ||
Secondary | Distant metastasis free survival | 1-3 years | ||
Secondary | Loco-regional control | 1-3 years |
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