Primary: • To evaluate the sensitivity and specificity of DWI-MRI to identify patients who will develop local failure after radio-chemotherapy of cervix cancer.Secondary: • To evaluate the sensitivity and specificity of MRI techniques including (T2-…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To evaluate the sensitivity and specificity of DWI-MRI to identify patients
who will develop local failure after radio-chemotherapy of cervix cancer
Secondary outcome
• To evaluate the sensitivity and specificity of MRI techniques including
(T2-weighted MRI, DCE-MRI) to identify patients who will develop local failure
after radio-chemotherapy of cervix cancer
• Determining whether there are differences in bias between centres. The
difference in bias will be assessed for the T1 and T2 scans and the Ktrans and
ADC maps.
• Comparison of DWI and T2 tumour volume delineation
Background summary
The Apparent Diffusion Coefficient (ADC) acquired by Diffusion Weighted Imaging
(DWI-MR) has been shown to correlate with cellular density. The ADC is
indicative of Gross Tumour Volume (GTV), and preliminary data shows that the
dynamics of DWI volumes during treatment (shrinkage) as well as dose to DWI
volumes has impact on treatment outcome.
Hypoxic tumour cells within the primary tumour have been identified to have
prognostic importance for local control Tumour hypoxia is caused by
insufficiency of the tumour vasculature leading to both chronic diffusion
limited and acute flow limited hypoxia. 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.
Functional imaging has the potential to visualise radioresistant tumour
subvolumes. Dynamic contrast enhanced (DCE) MR imaging has been used to
quantify the extent of poor perfusion regions within cervical tumours.
Study objective
Primary:
• To evaluate the sensitivity and specificity of DWI-MRI to identify patients
who will develop local failure after radio-chemotherapy of cervix cancer.
Secondary:
• To evaluate the sensitivity and specificity of MRI techniques including
(T2-weighted MRI, DCE-MRI) to identify patients who will develop local failure
after radio-chemotherapy of cervix cancer
• Determining whether there are differences in bias between centres. The
difference in bias will be assessed for the T1 and T2 scans and the Ktrans and
ADC maps.
• Comparison of DWI and T2 tumour volume delineation
Study design
observational prospective, non-randomized study
Intervention
The standard MRI scan which will be repeated 3 times extra (before start RT and
twice in FU). All other MRIs are part of regular clinical procedures but have
as extra the administration of 15 ml contrast
Study burden and risks
Patient will have an extra 3 MRI scans. In all MRI scans (standard as extra) 15
ml of the contast agent Dotarem will be adminstrated. No adverse reaction are
known but an allergic reaction can not be ruled out.
The scans will be done during regular hospital visits but extend the visits
with 40 minutes
Plesmanlaan 121
AMSTERDAM 1066 CX
NL
Plesmanlaan 121
AMSTERDAM 1066 CX
NL
Listed location countries
Age
Inclusion criteria
• Patients with locally advanced cervical cancer FIGO stage IB2-IV referred for definitive radio-chemotherapy
• Patients where MR guided brachytherapy is part of standard patient treatment
• Patients without previous record of allergic reaction to infusion of protocol related contrast media (Gadolinium-based for MR-imaging)
• Patients with sufficient kidney function according to local regulations
• Patients of 18 years age and over
• Cancer of the uterine cervix considered suitable for curative treatment
• Positive biopsy showing SQ, AdCA, AdAQ.
• Staging according to FIGO and TNM performed
• MRI pelvis at diagnosis available
• MRI, CT or PET-CT retroperitoneum and abdomen at diagnosis available
• MRI pelvis with applicator at BT will be performed
• Patient informed consent
Exclusion criteria
• Patients receiving neoadjuvant chemotherapy, hyperthermia or other antineoplastic treatments
• Patients with contra indications to MRI
• GFR < 30 ml/min/1.73 m2
• Patients with active infection or severe medical condition
• Patients pregnant, lactating or with childbearing potential without adequate contraception.
• Other primary malignancies
• Metastatic disease beyond paraaortic region (L1-L2)
• Previous pelvic radiotherapy
• Previous total or partial hysterectomy
• Combination of preoperative radiotherapy with surgery
• Patients receiving Brachytherapy (BT) only
• Patients receiving External Beam Radio Therapy only
• Contra indication to BT
Design
Recruitment
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 | NL47482.031.13 |