Determination of dielectric properties by MRI in women with cervical cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurement of variation in pelvic anatomy in patients with cervical cancer by
MRI, and the variation in corresponding distribution (and inaccuracy of
measurement) of dieletric properties, and the assessment of these variations on
subsequent HT treatment planning (in silico). (Note: HT in patients is not a
part of this study).
Secondary outcome
-
Background summary
Hyperthermia (HT) in oncology is defined as heating of the tumour to 42-43 oC
during 1 tot 1.5 hours. HT is one of the most potent sensitizers of
radiotherapy (RT) against cancer. A randomized study from the AMC and ErasmusMC
has shown that HT improves survival of women with inoperable cervical cancer
from 40% after RT-alone to 60% after RT+HT. However, optimal delivery and
effect of HT depends of the highly variable dielectric and thermal properties
of tumour and normal tissue. Treatment planning can yield optimal HT delivery
when the dielectric tissue properties are known. Magnetic resonance imaging
(MRI) can help to measure these dielectric properties.
Study objective
Determination of dielectric properties by MRI in women with cervical cancer.
Study design
Observational study.
Intervention: Standard MRI with scopolamine (10 mg supp.) and intravenous
contrast in patients with cervical cancer (40 minutes). The study-protocol is
extended with extra measurements, so-called B1 mapping by spin-echo sequence
using a 3 Tesla MRI. This requires extra time (20 minutes).
Study burden and risks
- Time: MRI sampling: ~60 minutes
- Pre-medication: Scopolamine 10 mg supp.
- Intravenous gadolinium contrast: One time intravenous administrations of
standard gadolinium contrast (Gadovist®). Gadovist® is a safe contrast medium,
although allergic reactions have been reported in 0.07% [Dilman, 2007]. Dosage
= body weight * 0.1 ml (1 µmol/l; usually 6 to 8 ml per patient). The i.v.
device will stay in situ until the end of the MRI-scanning to allow in case of
emergency, a rapid i.v. anti-allergic drug.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
20 adult patients with newly diagnosed cervical cancer undergoing tumour staging by MRI, and
Exclusion criteria
• Inability of the patient to provide informed consent or legally incompetent/incapacitated to do so,
• Presence of metal in the body (e.g. osteosynthetic material, pacemaker, artificial cardiac valves, brain clips),
• Claustrophobia
• Pregnancy
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 | NL42126.018.12 |