We will measure correlations between serially measured MRI parameters (pretreatment and early during treatment) and therapy outcome (response, locoregional recurrence and overall survival) in patients with HNSCC undergoing chemoradiation (CRT)…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Head and neck squamous cell carcinoma (HNSCC) is the 6th most common malignancy
worldwide, with 890,000 patients diagnosed and 450,000 patients dying from this
disease each year. For locally advanced diseases, multimodality treatment (e.g.
CRT) is required. Still, the 5-year survival rate lags at 40-60% with around
half of patients experiencing disease recurrence within the first two years.
Currently, patients with advanced stage are typically treated with a standard
pre-defined population-based CRT regime, typically administered during seven
weeks. CRT targets the tumorous tissue but also inflicts damage to healthy
tissue. Treatment response varies among patients, in which some have good
responses and might benefit from a reduction of doses to avoid unnecessary
toxicity due to overtreatment. Others are confronted with an incomplete
response, who possibly benefit from intensification of treatment or switch to
salvage surgery. Predictive biomarkers, based on the tumor biological
phenotype, can determine the tumour's response to CRT early on in this
treatment, and might enable individualization of therapy regimen based on
tumour response. This would lead to a more effective and personalized treatment
with fewer side effects.
Quantitative MRI has great potential as a predictive biomarker for response
assessment as it allows accessing local tissue microstructural properties,
probing cell density (IVIM-DWI), tissue perfusion (DCE & IVIM-DWI) and hypoxia
(T2*-relaxometry). lt was shown that baseline values of these parameters
correlate to overall survival and that changes early in the treatment can be a
biomarker for predicting locoregional recurrence free survival.
In this research, we will investigate a combination of quantitative MRI to
identify potential biomarkers tor predicting response to (chemo)radiotherapy
early on in the treatment.
Study objective
We will measure correlations between serially measured MRI parameters
(pretreatment and early during treatment) and therapy outcome (response,
locoregional recurrence and overall survival) in patients with HNSCC undergoing
chemoradiation (CRT) treatment, which will ultimately enable tailoring
treatment to be more patient-specific.
Study design
This is a single-center prospective study. In total 30 head and neck cancer
patients receiving standard-of-care CRT will be included who will undergo
pretreatment quantitative MRI, and intratreatment (2-3 weeks after treatment
initiation) quantitative MRI. Hence, we will obtain IVIM-DWI, DCE,
T2*-relaxometry at baseline and 2-3 weeks after the start of CRT in 30 HNSCC
patients treated with curative CRT.
MRI will be obtained at Amsterdam UMC (location VUmc) using a 3T MRI scanner.
MRI analysis will be done two-fold, once with our state of-the-art in-house
machine-learning-based pipeline, and once using CE labelled software (OLEA,
Canon Medical). As a standard of care in this patient group, patients with
HNSCC undergoing chemoradiation treatment will have blood samples drawn using
the consent procedure and infrastructure of the Liquid Biopsy Center (LBC)
Biobank Head and Neck Oncology of the Cancer Center Amsterdam.
Study burden and risks
During study participation, participants will undergo one additional
non-invasive MRI during treatment to obtain the imaging features.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84371.018.23 |