Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02973828 |
| Other study ID # |
CCR4576 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 17, 2017 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Institute of Cancer Research, United Kingdom |
| Contact |
Greta Bucinskaite |
| Phone |
+44 20 3186 5157 |
| Email |
greta.bucinskaite[@]rmh.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment
to locate the tumour and ensure the radiation is hitting the target.
These x-rays expose patients to additional radiation and the quality of these scans is often
poor which makes it difficult to distinguish tumour from normal tissue and there may be
uncertainty in the tumour position due to movement or shrinkage. To allow for these
uncertainties a large margin around the tumour is also treated, but this means that large
volumes of normal tissue also receive significant doses of radiation, which can result in
early and late toxicity.
MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the
difference between tumour and normal tissues and does not expose patients to additional
radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear
accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the
Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently
installation a prototype, which will be one of the first in the world. This revolutionary
technology has the potential to change the way radiotherapy is delivered. We hope the
improved precision and accuracy in hitting the target will mean reductions in margins around
tumours and that this will lead to higher cure rates with significantly fewer side effects.
Studies are required to simulate treatment on the MR Linac before it can be used in routine
clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and
patients who are currently undergoing treatment. This study will involve imaging with MRI in
healthy volunteers as well as in patient volunteers before and during their standard course
of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR
Linac-based research focusing on clinical application and establishment into a MR-CT and MR
only workflow, treatment adaptation and quality assurance.
Description:
This is a study protocol for the acquisition of MR Linac derived images with a view to MRIgRT
for patients undergoing radiotherapy with radical intent at sites predicted to benefit most
from MRIgRT (namely, for rectum, cervix, lung, prostate, bladder, breast, brain, oesophagus,
head and neck, hepato-pancreato-biliary (HPB) and paediatric abdomino-thoracic cancers).
These will be used to build a database of MR images for MR Linac-based research focusing on
clinical application and establishment into a MR-CT and MR only workflow, treatment
adaptation and quality assurance. The primary aims are to 1) develop MR Linac image sequences
suitable for seeing tumour/target and normal tissue at the time of radiotherapy and 2)
determine variations in image registrations and tissue contouring using the MR Linac images.
Four stages of imaging development sub-studies will be included in this protocol for
optimisation of MR imaging on the MR Linac. Consideration will be given to image quality,
scan times, and IT requirements for reconstruction, storage and image transfer.
These imaging sub-studies will be:
A) Non-patient Volunteer Imaging Studies of Normal Tissue (n = 18 - 54 per centre). The four
anatomical regions selected to be studied are Head and neck, Thorax (chest wall/breast and
lung/oesophagus), Abdomen and Pelvis (male and female). Recruitment will continue until
imaging from a minimum of three consecutive patients using the same 'exam card' are deemed to
be acceptable for normal tissue visualisation for each anatomical site.
B) Patient Volunteer Imaging Studies of Normal Tissue (n = 39 - 72 per centre). We will
further develop the protocols to visualise site specific tumours in 13 target areas (brain,
oropharynx/larynx/hypopharynx, oesophagus, lung, chest wall _+/- regional lymph nodes),
paediatric abdomen-thoracic cancers, hepatobiliary tract, bladder, gynaecology, prostate,
rectum, oligomets bone and oliogmets soft tissue). Patients will be recruited for imaging for
a minimum of one and maximum of 12 imaging sessions whilst undergoing radiotherapy planning
and/or radiotherapy treatment. Repeat imaging will allow for the determination of protocol
robustness. The aim will be to produce images appropriate for tumour and normal tissue
visualisation with a view to directing radiotherapy. Recruitment will continue until imaging
from a minimum of three consecutive patients using the same 'exam card' are deemed to be
acceptable for tumour/target visualisation at each site.
C) Pathway development studies (n = 39 - 208 per centre). At each centre, it is estimated
that 16 imaging sessions per tumour site are required for inter and intra registration
observer variability. To establish library of images to be used to develop adaptive
radiotherapy workflows, up to 50 imaging sessions may be required depending on the tumour
site. Images for normal tissue and tumour visualisation will also be used to refine exam
cards from Stage B.
This stage requires a minimum of three patient volunteers to be recruited to each tumour site
which may (or may not) include images acquired in the previous Stage B of the study, and a
maximum of 16 patient volunteers to reach the desired number of imaging sessions. Each
volunteer should undergo a minimum of two and not more than twelve imaging sessions (max
1/day, 3/week). The methodology of image acquisition will follow methodology for Stage B as
above. The primary aim will be to establish that both online and offline image-matching using
MR Linac with a view to guiding radiotherapy treatments can be undertaken with minimal intra
and inter user variability. Development of treatment workflow to help implement radiotherapy
treatment on the MR Linac can also be carried out. Refined exam cards from Stage B but fine
tuning as necessary can be used to acquire sets of images and to use this information to plan
treatment by simulating an on-line treatment whilst not delivering radiation.
D) On-going image development and continuous quality improvement of images
This stage of the study can run in parallel, subsequent to or independently of stages B and
C. The purpose will be to recruit patients receiving radiotherapy, non-radiotherapy cancer
patients or non-patient volunteers in order to optimise MRI guided radiotherapy delivery.
Examples of this include, investigating suitability of radiotherapy immobilisation devices
for patient positioning and treatment set-up development and/or development of new/novel
imaging sequences, optimisation of existing sequences and undertaking continuing image
quality improvement for the tumour sites listed in this protocol. Adult patient with cancers
not conventionally treated using radiotherapy could be recruited in order to investigate
whether radiotherapy could be used as a treatment modality in the future. Patients with
unusual or rare cancer (for example sarcoma, kidney and lymphoma) that do receive
radiotherapy could be recruited to investigate the benefit of using the MR Linac for cancers
of this type.
The total number of volunteers is, as yet, unknown; however the recruitment progress will be
monitored by the trial management group (TMG). The TMG will ensure that this protocol is
being adhered to, that all volunteers are being imaged safely and that the information gained
from the imaging sessions is being used appropriately. The investigator may recruit between
one and five volunteers (patient, non- radiotherapy patient or non patient). On going
evaluation of technique MRI sequence and/or equipment etc should be carried out to determine
number of required volunteers with a maximum of 5 repeated imaging sessions per volunteer.
The TMG can restrict the maximum number of volunteers and repeated imaging sessions, if
appropriate.
A maximum of 150 volunteers will be recruited to this section of the study
