Neoplasms Clinical Trial
Official title:
Quantitative MR Imaging in Locally Advanced Cervical Cancer Sub-study Under the EMBRACE II Protocol
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
and lowers the rate of distant disease control. DCE MR imaging 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 MR 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).
Radiotherapy is an important treatment modality in the management of cancers of the uterine
cervix. About half of patients with cervical cancer receive definitive radiotherapy in the
course of their disease. Radiotherapy is most often administered as a combination of external
beam radiotherapy (EBRT) and brachytherapy (BT). In the late 90's a major breakthrough in
cervical cancer radiotherapy took place with the introduction of MR image guidance of BT. By
performing MR imaging before each BT implant it is possible adapt the dose given by BT to the
anatomy of each individual patient taking into account not only the position of organs at
risk (bladder, rectum and sigmoid) but also the tumour regression induced by the preceding
EBRT and chemotherapy.
Functional imaging that reflects hypoxia, metabolism, heamodynamics and tissue structure have
been applied to locally advanced cervical cancer with the goal to identify imaging markers
that may predict outcome early on and improve tissue classification. DCE-MRI may be the most
investigated so far for locally advanced cervical cancer. A comprehensive literature review
including papers investigating the prognostic value of DCE-MRI in patients with locally
advanced cervical cancer identified 20 papers from 10 research groups, with a median number
of 30 patients (range 7-102 patients). A total number of 17 papers publish a positive
association between pre-treatment DCE-MRI and outcome in terms of local control or disease
free survival (1-17). However, not all studies present independent cohorts of patients. Three
papers show no effect (18-20) The studies on cervical cancer points in the direction that
DCE-MRI has the capability to identify aggressive forms of cervical cancer, and that the
pre-treatment measurements may serve as, predictive markers for outcome after
chemo-radiotherapy. The largest studies indicate that in particular the tumour fraction with
the lowest signal enhancement is an important parameter, though the diversity in methodology
is significant.
Diffusion weighted MRI (DWI-MRI) has to a lesser extent than DCE-MRI been investigated in
locally advanced cervical cancer. Most studies using DWI-MRI in cervical cancer have
investigated its diagnostic capabilities (21-28) all concluding high sensitivity and
specificity (review by Kundu et al. (29)). The Toronto group; McVeight et al. (26) and later
Gladwish et al. (30) found prior to the onset of treatment that the highest 90th % ADC value
correlated with response, similar finding was found by the group in Tianjin; Liu et al. (22).
Both groups found that higher ADC value insides the tumour was predictive of poor response to
treatment and suggest the higher ADC to be connected to tumour necrosis. When tumour
necrosis, occur there is loss of cell membrane integrity and therefore an increase in the
extracellular volume and a decrease in intracellular volume effectively increasing the ADC.
Conversely, the group from London UK; Harry et al. (31) and Somoye et al. (32) showed no
correlation to treatment response at the time prior to treatment. Instead the ADC at 2 weeks
(and the change in ADC) into treatment was predictive of treatment response and prognostic of
patient outcome. Finally, Marconi et al. (33) found a relation between minimum ADC in the
tumor and both DSS and DFS.
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.
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