* The primary objective is: the quantification of bowel motility in gynecological cancer patients undergoing radiotherapy using MRI. * The Secondary objectives are: - assessment of bowel motility variation within a patient during their treatment…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter of the study is to quantify bowel motility in three
orthogonal directions in gynecological cancer patients treated with definitive
radiotherapy using MRI.
Secondary outcome
The secondary study parameters/endpoints are :
- assessment of bowel motility variation within a patient during their
treatment course.
- assessment of bowel motility variation between patients with a focus on
changes of bowel motility associated with major abdominal surgery.
Background summary
To reduce the risk of bowel toxicity in gynecological malignancies patients
undergoing curative radiotherapy, irradiation of organs at risk (OARs) (i.e.
bowel and bladder ) should be minimized. Gynecological malignancies are
standardly irradiated with high radiation doses, typically delivered by
external beam radiotherapy (EBRT) sessions followed by one or two brachytherapy
(BT) sessions. During the treatment course, patients undergo three or four
magnetic resonance imaging (MRI) scans, which are used for treatment planning.
Based on the delineated tumor and OARs, radiation doses are calculated.
However, variation in bowel position due to bowel motility can result in
unpredictable dose distributions with the risk of exceeding the planned doses.
Deviating from the planned dose may lead to increased risk of severe acute and
late/chronic bowel toxicity. Therefore, bowel motility during radiation should
ideally be taken in account and integrated in the treatment planning. However,
until to date, methods for assessing bowel motility during radiotherapy
treatment are non-existing.
In this pilot study, we aim to quantify bowel motility in gynecological cancer
patients undergoing radiotherapy using MRI. Furthermore, to gain more
understanding about bowel motility in this patient group, we would also like to
assess variation in bowel motility induced by several factors (for example
radiation, patient preparation for brachytherapy and previous major abdominal
surgery). MRI provides 3D images with good quality for accurate motility
assessment. In addition, MRI is a non-invasive modality with no radiation
burden making it the best tool for this pilot study.
Study objective
* The primary objective is:
the quantification of bowel motility in gynecological cancer patients
undergoing radiotherapy using MRI.
* The Secondary objectives are:
- assessment of bowel motility variation within a patient during
their treatment course.
- assessment of bowel motility variation between patients with a
focus on changes of bowel motility associated with major abdominal
surgery.
Study design
This pilot study will be conducted in ten gynecological cancer patients
undergoing definitive radiotherapy with curative intent. In the standard care,
patients undergo 3 to 4 MRI scans at different time points (prior to and during
radiotherapy). To quantify bowel motility, an extra MRI sequence (10 min) will
be added to the standard MRI scans (45 min). From the obtained MRI scans, bowel
motility will be quantified. Bowel motility will be expressed as bowel
displacement in three orthogonal directions. The motility between the MRI scans
will be compared within and between patient in order to assess the effect of
radiation, patient preparation and abdominal surgery in the past on bowel
motility.
Study burden and risks
The additional motility MRI sequence will be added to each standard MRI scans
(45 min, three to four times). Each motility scan will take about 10 minutes.
The burden during the entire treatment course will be thus extra 30-40 minutes
scan time over a period of seven to eight weeks. Since MRI is not invasive with
no radiation burden, patients are not susceptible to radiation hazards.
However, being in a MRI for about an hour can be uncomfortable, therefore
patients are free to halt the procedure and withdraw from the motility MRI scan
at any time. Patients will not benefit from participation in this study.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
* age >18 years
* Treatment plan: Definitive radiotherapy with curative intent ± chemotherapy
or hyperthermia
* Tumor type and stage:
- Cervical carcinoma (FIGO IB-IVA).
- Vaginal carcinoma (FIGO I-IVA).
- Isolated vaginal recurrence of endometrial carcinoma.
* Written informed consent
Exclusion criteria
* Claustrophobia
* Any 3T MRI contra-indications stated by the AMC MRI safety committee (See
protocol appendix A)
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 | NL65554.018.18 |