Brief Title
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Official Title
Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Brief Summary
uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
Detailed Description
To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues. The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer: Study I: Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0) Study II: Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
Secondary Outcome
Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).
Condition
Oral Cancer
Intervention
68Ga-NOTA-AE105 PET/CT
Study Arms / Comparison Groups
68Ga-NOTA-AE105 PET/CT
Description: One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
90
Start Date
November 2016
Completion Date
August 2018
Primary Completion Date
August 2018
Eligibility Criteria
Inclusion Criteria: - Able to understand patient information and to give informed consent - Not previously irradiated or operated on neck - Operable disease Study I OSCC cN0 verified histologically by pathologic examination of biopsy Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy Exclusion Criteria: - Pregnancy - Patients who are candidates for curative intentional radiation - Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage. - Other diseases assessed by the investigator as basis for exclusion. - Age under 18 or over 85 years - Obesity> 140 kg - Allergy to 68Ga-NOTA-AE105
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Andreas Kjær, MD,DMSc,PhD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02960724
Organization ID
AK-2016-HHC1
Responsible Party
Principal Investigator
Study Sponsor
Rigshospitalet, Denmark
Study Sponsor
Andreas Kjær, MD,DMSc,PhD, Study Director, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Verification Date
November 2016