Primary: To evaluate the sensitivity and specificity of dynamic contrast enhanced (DCE-MRI) to identify patients who have increased risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer.Secondary: To apply…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Kinetic modelling will be applied in DCE-MRI images to assess quantitative
kinetic parameters in the gross tumour volume related to blood volume,
interstitial volume, flow and permeability. It will be tested whether different
thresholds of haemodynamic parameters can predict disease free survival.
Secondary outcome
We will investigate the use of machine learning techniques such as radiomics
and deep learning in computer aided detection (CAD) of the primary lesion. The
features used for this task will comprise of the full set and subsets of the
functional and textural parameters extracted from DWI, DCE and qT2. The
accuracy of the learned algorithm will be evaluated on a separate validation
set with expert delineated primary lesion or a leave-one-out-cross validation.
Furthermore the DWI and qT2 will be tested whether they may predict disease
free survival separately. The combination of all extracted functional (DCE,
DWI, qT2) and textural features will be used to train a machine learning
algorithm separating the classes: patients with and without disease free
survival.
Potential bias between centres will be evaluated for quantitave T2,
quantitative DWI and DCE MRI parameters using ANOVA analysis. For DWI: the ADC
(median tumour values) will be evaluated for assessment of any center-effect.
Background summary
Hypoxic tumour cells within the primary tumour have shown prognostic importance
for local and metastatic disease control in several cancer sites.
Radioresistant hypoxic cells diminish the rate of local control, and the
hypoxia driven increase in metastatic potential of the tumour lowers the rate
of distant disease control. DCE MRI has been used to quantify the extent of
poor perfusion regions within cervical tumours and it has been shown to be a
surrogate of hypoxia. Furthermore, a number of studies have demonstrated that
DCE MRI is predictive of disease failure in cervix cancer.
The EMBRACE II study will implement an imaging sub-study, which will evaluate
the value of quantitative MR imaging to identify patients at increased risk of
disease recurrence (local, nodal and systemic).
Study objective
Primary: To evaluate the sensitivity and specificity of dynamic contrast
enhanced (DCE-MRI) to identify patients who have increased risk of disease
recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer.
Secondary: To apply radiomics for identification of patients who have increased
risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of
cervix cancer. Radiomics analysis will include features from DCE-MRI, DWI and
quantitative T2 imaging.
Secondary: To correlate MR imaging parameters with biomarkers based on
pathology (immunohistochemistry, genomic analysis), in a subgroup of patients
Secondary: To evaluate the implementation of quantitative imaging in a
multicentre setting.
Study design
This is an observational prospective, non-randomized study in which patients
with locally advanced cervical cancer included in the EMBRACE II study can
enroll. The study will be carried out in 8-15 EMBRACE centres.
MRI will be carried out prior to radiotherapy. The details of the MRI exams
will differ from standard clinical practice in the centres, but will be
consistent with international guidelines for cervix MRI. The exam will include
T1, T2, diffusion, and dynamic contrast-enhanced imaging. At time of
brachytherapy, the treatment planning MRI will additionally include DWI and qT2.
Patients will be followed up according to the EMBRACE II follow-up schedule.
Study burden and risks
For the standard DCE-MRI exam, 0.1mmol/kg of the contrast agent Dotarem
(Gadoteric Acid, concentration 0.5M) is administered intravenously where minor
patient discomfort may occur.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
* Patients included in the EMBRACE II study (see inclusion criteria in the
EMBRACE II protocol)
* Patients without previous record of allergic reaction to infusion of protocol
related contrast media (Gadolinium-based)
* Patients with sufficient kidney function according to local regulations
Exclusion criteria
* According to EMBRACE II protocol
* Patients with active infection or severe medical condition
* GFR < 30 ml/min/1,73 m²
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT03210428 |
| CCMO | NL62329.058.17 |