Evaluation of tumor response during and after (chemo)radiotherapy for patients with oropharyngeal squamous cell carcinoma using functional imaging by diffusion-weighted MRI
Withdrawn
- Conditions
- 10027655Oropharynx cancerthroat cancer
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients with histological proven squamous cell carcinoma of the orpharynx scheduled for (chemo)radiotherapy.
Exclusion Criteria
-Patients with recurrence of previously confirmed head and neck squamous cell carcinoma.
-Patients undergoing any other treatment option for the primary tumor like surgery.
-Patients with other types of head and neck malignancies: lymphatic neoplasms, esophageal malignancies, thyroid cancer, lip cancer, skin cancers and other malignancies not originating from the pharynx.
-Having any physical or mental status that interferes with the informed consent procedure.
-Contraindications for MRI (e.g. claustrophobia, arterial clips in central nervous system)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Study parameters:<br /><br>Functional changes (ADC values)<br /><br>The diffusion-weighted images will be analyzed on a PACS-station.<br /><br>The ADC changes (*ADCN ) in % for each lesion between the baseline and the time<br /><br>point of response evaluation are calculated using the formula:<br /><br>*ADC4=[(ADC4 -ADCB)/ADCB]*100<br /><br>*ADCa=[(ADCa -ADCB)/ADCB]*100<br /><br>ADCB represents pretreatment ADC-value<br /><br>ADC4 represents the ADC-value at the 4th week of treatment, and<br /><br>ADCa represents the ADC-value three week after treatment.<br /><br><br /><br>structural (volume) changes<br /><br>Location, volume and size of primary tumor and enlarged lymph nodes will be<br /><br>measured on the T2-weighted and contrast-enhanced T1-weighted images. </p><br>
- Secondary Outcome Measures
Name Time Method <p>There are no secundary parameters</p><br>