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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56710

Enrollment

Registered

2024-02-27

Start date

2023-11-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

head and neck cancer squamous cell carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Each of the following criteria will result in exclusion from participation in this study: 1) Age

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results