uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Study Details
Study Description
Brief Summary
uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-NOTA-AE105 PET/CT 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. |
Other: 68Ga-NOTA-AE105 PET/CT
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
- 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]
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Study Director: Andreas Kjær, MD,DMSc,PhD, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK-2016-HHC1