Functional Imaging during Radiation Therapy for HNC using FDG-PET, HX4-PET and MRI
- Conditions
- Head and Neck Cancer10027655
- Registration Number
- NL-OMON42671
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 56
- Histologic biopsy confirmed SCC oral cavity, oropharynx, hypopharynx, and larynx
- HPV negative tumors
- Largest tumor diameter at least 3 cm (primary tumor)
- Scheduled for concurrent chemoradiotherapy or definitive external beam radiotherapy (DAHANCA schedule and normal fractionation are both applicable)
- SCC of the nasopharynx, nasal cavity, paranasal sinuses, salivary gland and thyroid gland
- Expected failure from follow-up
- Patients who are not expected to participate in at least 2 out of 3 imaging modalities (MRI, HX4-PET and FDG-PET)
- Pregnancy or lactation
- Patients (M/F) with reproductive potential not implementing adequate contraceptives measures at least 14 days before the first study procedure
- Prior surgery, radiotherapy or chemotherapy for this tumor
- Previous malignancies within the last 2 years except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determining the Ktrans, ADC, FDG-PET SUV en HX4-PET SUV signal changes during<br /><br>radiotherapy. Calculating the differentiating abilities between patients with<br /><br>and without a recurrence of these signal changes</p><br>
- Secondary Outcome Measures
Name Time Method <p>Determine the correlation between the average signal changes during treatment<br /><br>of the different modalities.<br /><br>Determine the signal heterogeneity within the treatment and the heterogeneity<br /><br>differences between patients.<br /><br>Determine the prognostic value of the change in tumor volume.</p><br>