Investigation of pelvic blood circulation by MRI in women with a gynaecological cancer who will have curative radiotherapy with or without weekly HT for inoperable pelvic tumours.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end-point is to show feasibility of perfusion MRI by determining
significant changes in blood circulation in HT and RT patients. Furthermore,
several secondary end-points aim at using the data for hypothesis generating
and retrieving the essential preliminary data to allow for designing more in
depth studies into using perfusion MRI as biomarker for HT efficacy.
Secondary outcome
See above.
Background summary
HT has different effects on cells and tissue that may explain the effects. At
temperatures >= 39-40°C, HT gives vasodilation. On the one hand, increased
circulation leads to an increased oxygen supply to the tumor, making the tumor
more sensitive to radiation (= increased tumor control). On the other hand,
increased circulation can increase cooling of the tumor, which could reduce the
effect on tumor cells. Blood flow to the tumor and surrounding tissue can be
measured by MRI. In this study we wish to investigate in patients the effect of
radiation with or without HT on the blood flow in tumor and in healthy tissues,
bfore, during the course of radiation and after radiotherapy.
Study objective
Investigation of pelvic blood circulation by MRI in women with a gynaecological
cancer who will have curative radiotherapy with or without weekly HT for
inoperable pelvic tumours.
Study design
A non-randomized prospective observational study in patients receiving daily RT
with weekly HT compared to patients who do not receive HT (who typically will
receive RT plus weekly chemotherapy). Patients will receive 3 standard MRIs at
several points before, after 3 weeks into treatment, and 3 months after
treatment. Each standard MRI takes about 20 min.
For study purposes:
- All patients will receive extra MRI scans during the standard MRI of 20
minutes, which include Dotorem contrast agent injection.
- between 10 to 30 patients who, as standard of care, have RT plus hyperthermia
will have 3 extra MRI scan moments (repeated baseline, a scan right after the
first and third HT session) of 40 minutes, of which 1 includes a Dotarem
contrast agent injection.
Study burden and risks
An MRI typically takes 20 min, adding administration of i.v. Gd-contrast, DCE
(~10 min) and intravoxel incoherent motion diffusion weighted MRI (IVIM-DWI)
(~10 min), will prolong the investigation to max. 40 min. Administration of
i.v. Gd-contrast is associated with a small risk of an allergic reaction, and
with extravasation and haematoma (erroneous administration of the i.v.
contrast) causing temporary discomfort.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All adult patients (18 years or older) with pelvic cancer who are possibly
eligible for curative radiotherapy with or without hyperthermia
- 18 years or older
- histologically confirmed primary pelvic tumour,
- possibly eligible for primary radiotherapy (with or without chemotherapy
and/or hyperthermia)
- able to understand and read Dutch or English,
- written informed consent (Dutch or English)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- all who do not comply to the inclusion criteria
- those with a contra-indication for MRI (i.e. MRI incompatible metal implants,
pacemaker, severe claustrophobia)
- those with a contra-indication for MRI-contrast agent (i.e. known allergic
reaction, poor functioning of the kidneys eGFR<30 mL·min*1·1.73 m*2)
- pregnancy
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.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 |
|---|---|
| CCMO | NL77270.018.21 |