The predictive value of PET-CT and PET-DW-MRI early during chemoradiotherapy for head and neck cancer

The predictive value of PET-CT and PET-DW-MRI early during chemoradiotherapy for locoregional control of advanced stage head and neck cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28050

Enrollment

Registered

2013-08-07

Start date

2013-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

None listed

Interventions

Two FDG-PET-CT and two PET-DW-MRI scans (including diffusion-weighted images) prior to therapy and during therapy (2 weeks after the start of radiotherapy).

Eligibility

Inclusion criteria

Inclusion criteria: - Squamous cell carcinoma - Oral cavity, pharynx or larynx - T2, T3 or T4 - Resectable (technically) - Primary chemoradiation (with curative intent)

Exclusion criteria

Exclusion criteria: - Age < 18 years - Pregnancy - Patients carrying a pacemaker, or unable to undergo an MRI

Design outcomes

Primary

Measure	Time frame
To investigate the diagnostic value of FDG-PET-CT and DW-MRI (EPI and non-EPI technique) applied 2 weeks after the start of primary chemoradiotherapy for HNSCC to predict locoregional response in the primary tumor and cervical node metastases.	—

Secondary

Measure	Time frame
To determine the value of different criteria, related to the primary objective, such as: • FDG uptake level pretreatment (on PET-CT and PET-MRI) • Residual FDG uptake level after 14 days of therapy (on PET-CT and PET-MRI) • Change of FDG uptake (on PET-CT and PET-MRI) • b=1000 signal intensity and ADC level pretreatment (for both EPI- and non-EPI-technique) • Residual b=1000 signal intensity and ADC level after 14 days of therapy (for both EPI- and non-EPI-technique) • Change of b=1000 signal intensity and ADC (for both EPI- and non-EPI-technique) FDG-uptake levels obtained from PET-CT and PET-MRI will be compared (taking into account the different time intervals between FDG-injection and scanning)	—

Measure

Time frame

To determine the value of different criteria, related to the primary objective, such as: • FDG uptake level pretreatment (on PET-CT and PET-MRI) • Residual FDG uptake level after 14 days of therapy (on PET-CT and PET-MRI) • Change of FDG uptake (on PET-CT and PET-MRI) • b=1000 signal intensity and ADC level pretreatment (for both EPI- and non-EPI-technique) • Residual b=1000 signal intensity and ADC level after 14 days of therapy (for both EPI- and non-EPI-technique) • Change of b=1000 signal intensity and ADC (for both EPI- and non-EPI-technique) FDG-uptake levels obtained from PET-CT and PET-MRI will be compared (taking into account the different time intervals between FDG-injection and scanning)

—

Contacts

Public ContactC.S. Schouten

Department of Otolaryngology/ Head and Neck surgery VU University Medical Center

cs.schouten@vumc.nl+31204440954

Outcome results