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Evaluation of tumor response during and after (chemo)radiotherapy for patients with oropharyngeal squamous cell carcinoma using functional imaging by diffusion-weighted MRI

Evaluation of tumor response during and after (chemo)radiotherapy for patients with oropharyngeal squamous cell carcinoma using functional imaging by diffusion-weighted MRI - PREDICT

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38623
Enrollment
40
Registered
2013-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharynx cancer throat cancer

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with histological proven squamous cell carcinoma of the orpharynx scheduled for (chemo)radiotherapy.

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Study parameters: Functional changes (ADC values) The diffusion-weighted images will be analyzed on a PACS-station. The ADC changes (*ADCN ) in % for each lesion between the baseline and the time point of response evaluation are calculated using the formula: *ADC4=[(ADC4 -ADCB)/ADCB]*100 *ADCa=[(ADCa -ADCB)/ADCB]*100 ADCB represents pretreatment ADC-value ADC4 represents the ADC-value at the 4th week of treatment, and ADCa represents the ADC-value three week after treatment. structural (volume) changes Location, volume and size of primary tumor and enlarged lymph nodes will be measured on the T2-weighted and contrast-enhanced T1-weighted images.

Secondary

MeasureTime frame
There are no secundary parameters

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)