Imaging of tumour microenvironment in patients with oropharyngeal head and neck squamous cell carcinoma using RGD PET/CT imaging.
Phase 2
Recruiting
- Conditions
- mouth- and throat cavity tumoursOropharyngeal squamous cell carcinomas10027655
- Registration Number
- NL-OMON47965
- Lead Sponsor
- Radiologie en Nucleaire Geneeskunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Patients with a histologically proven OHNSCC;
- P-16 immunohistochemical analysis to determine HPV status of the tumour;
- A primary tumour lesion with a diameter of at least 1.0 cm concluded from a
diagnostic CT, MRI or FDG PET/CT scan within 4 weeks prior to intake;
- Planned chemoradiotherapy as primary treatment;
- Age of at least 18 years;
- Ability to provide written informed consent.
Exclusion Criteria
- Contra-indication for (PET/)CT: Pregnancy; Breast-feeding; Severe
claustrophobia.
- Contra-indication for administration of iodine-containing contrast agents.
- Other serious illness, e.g. history of malignancies
- Estimated creatinine clearance <= 30 mL/min according to the Cockcroft-Gault
formula
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to assess the differences in<br /><br>[68Ga]Ga-RGD2 uptake and quantitative CT perfusion parameters between HPV+<br /><br>oropharyngeal HNSCC tumours and HPV- oropharyngeal HNSCC tumours in patients<br /><br>who will be treated with chemoradiotherapy. Furthermore, the changes in<br /><br>[68Ga]Ga-RGD2 uptake and CT perfusion parameters in tumours before and during<br /><br>chemoradiotherapy will be investigated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To explore the correlation between the PET/CT and CT perfusion scans and<br /><br>locoregional control at one year follow-up.</p><br>