Determination of tissue perfusion and dielelectric properties by MRI in women with cervical cancer.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of electric tissue properties and perfusion in patients with
cervical cancer by MRI, and the variation in corresponding distribution during
the course of radiotherapy (plus chemotherapy or hyperthermia).
Secondary outcome
None.
Background summary
Hyperthermia (HT) in oncology is defined as heating of the tumour to 42-43 C
during 1 tot 1.5 hours. HT is one of the most potent sensitizers of
radiotherapy (RT) against cancer; for instance, HT and has shown to improve
survival of women with inoperable cervical cancer from 40% after RT-alone to
60% . However, optimal delivery and effect of HT depends of thermal properties
of tumour and normal tissue: the dielectric properties and perfusion. Magnetic
resonance imaging (MRI) can help to measure these properties.
Study objective
Determination of tissue perfusion and dielelectric properties by MRI in women
with cervical cancer.
Study design
Observational study
Study burden and risks
- Time: MRI sampling: ~60 minutes
- Intravenous gadolinium contrast: One time intravenous administrations of
standard gadolinium contrast (Gadovist®) will be administered. 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
Forty women with newly diagnosed inoperable cervical cancer will receive the standard MRI (40 min) plus experimental protocol (20 min). Twenty women who will receive primary radiotherapy (plus standard chemotherapy or hyperthermia) will also receive extension with 2 standard MRIs required for treatment monitoring during radiotherapy (40 min) with the experimental protocol (~20 min).
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),
• Claustrophobia
• Pregnancy
• Previous adversary reaction to Gadovist-i.v. contrast
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 | NL55833.018.15 |