Neoplasms Clinical Trial
Official title:
Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Persson M, Nedergaard MK, Brandt-Larsen M, Skovgaard D, Jørgensen JT, Michaelsen SR, Madsen J, Lassen U, Poulsen HS, Kjaer A. Urokinase-Type Plasminogen Activator Receptor as a Potential PET Biomarker in Glioblastoma. J Nucl Med. 2016 Feb;57(2):272-8. doi — View Citation
Persson M, Skovgaard D, Brandt-Larsen M, Christensen C, Madsen J, Nielsen CH, Thurison T, Klausen TL, Holm S, Loft A, Berthelsen AK, Ploug M, Pappot H, Brasso K, Kroman N, Højgaard L, Kjaer A. First-in-human uPAR PET: Imaging of Cancer Aggressiveness. The — View Citation
Skovgaard D, Persson M, Brandt-Larsen M, Christensen C, Madsen J, Klausen TL, Holm S, Andersen FL, Loft A, Berthelsen AK, Pappot H, Brasso K, Kroman N, Hoejgaard L, Kjaer A. Safety, dosimetry and tumor detection ability of 68Ga-NOTA-AE105 - a novel radiol — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings. | Through study completion, an average of 1.5 year | No | |
Secondary | 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). | Through study completion, an average of 1.5 year | No | |
Secondary | Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma. | Through study completion, an average of 1.5 year | No | |
Secondary | Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist) | Through study completion, an average of 1.5 year | No |
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