The value of combined Quantitative MRI for Treatment Response Assessment in head and neck cancer patients receiving (Chemo)radiotherapy.

Conditions: head and neck cancer
squamous cell carcinoma
10038666

Registration Number: NL-OMON56710

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1) Newly diagnosed tumours classified as stage T2-4 N0-2 located in the larynx,
oropharynx or hypopharynx
(unknown primary and oral cavity are not eligible)
2) Histopathological diagnosis of invasive squamous cell carcinoma in the
primary tumour
3) (Chemo)Radiotherapy planned to start within 6 weeks from baseline imaging of
tumour assessment
4) No distant metastasis (M0)
5) WHO performance status 0-2
6) >= 18 years of age
7) Written informed consent signed by the patient

Exclusion Criteria

Each of the following criteria will result in exclusion from participation in
this study:
1) Age < 18 years
2) Pregnancy
3) Patients carrying a pacemaker, or unable to undergo an MRI on a 3T MRI
scanner
4) Primary tumour of the oral cavity or unknown primary tumour
5) Prior or current anticancer treatment to the head and neck area (e.g.
radical attempted or tumour
reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or
radiotherapy),
except for endoscopic glottic laser micro surgery.
6) Current participation in any other interventional clinical study.
7) History of previous malignancy within the last 3 years.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the univariate prognostic value of potential pre- and intratreatment<br /><br>(2-3 weeks after start of CRT) quantitative functional MRI parameters (D,<br /><br>Ktrans or T2*) as candidate biomarkers to predict loco-regional failure in<br /><br>patients with head and neck squamous cell carcinoma within 2 years after<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>I. To assess the univariate predictive of pre- and intratreatment (2-3 weeks<br /><br>after start of CRT) quantitative functional MRI parameters (D, Ktrans or T2*)<br /><br>to predict distant metastasis and overall survival in patients with head and<br /><br>neck squamous cell carcinoma within 2 years after treatment. II. To assess the<br /><br>effect of CRT on the functional biomarkers after 2-3 weeks of treatment<br /><br>initiation. III. To compare in-house state-of-the-art processing software to<br /><br>CE-labelled analysis pipeline. IV. To assess the correlation of MRI parameters<br /><br>and liquid biopsy findings to test whether both techniques are complementary to<br /><br>each other.</p><br>