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Functional Imaging during Radiation Therapy for HNC using FDG-PET, HX4-PET and MRI

Functional Imaging during Radiation Therapy for HNC using FDG-PET, HX4-PET and MRI - FAITH

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42671
Enrollment
56
Registered
2016-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Head and Neck Cancer

Interventions

additional diagnostic scans - 4 x FDG-PET/CT - 4 x MRI - 3 x HX4-PET/CT

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Determining the Ktrans, ADC, FDG-PET SUV en HX4-PET SUV signal changes during radiotherapy. Calculating the differentiating abilities between patients with and without a recurrence of these signal changes

Secondary

MeasureTime frame
Determine the correlation between the average signal changes during treatment of the different modalities. Determine the signal heterogeneity within the treatment and the heterogeneity differences between patients. Determine the prognostic value of the change in tumor volume.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)