Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04275921 |
| Other study ID # |
CO996 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 16, 2018 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
February 2020 |
| Source |
The Clatterbridge Cancer Centre NHS Foundation Trust |
| Contact |
Maria Maguire, PhD |
| Phone |
0151 556 |
| Email |
maria.maguire2[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to investigate the use of Magnetic Resonance Imaging (MRI) in
the diagnostic and planning phase of radiotherapy for lung cancer and then introduce it into
on-treatment imaging to improve the accuracy of radiotherapy. The study compromises of two
phases, a technical phase followed by a clinical phase.
The aim of the technical phase is to develop and test MR sequences using a diagnostic scanner
for use in the chest.
This will be carried out on a humanoid phantom and subsequently healthy volunteers.
The second phase will be a clinical phase to assess the accuracy of visualising all thoracic
structures and the tumour in lung cancer patients using the defined MR sequences. It will
compromise of 2 parts; the first part will involve 3 lung cancer patients as a pilot to
enable the fine tuning of the sequences. The 2nd part will involve the evaluation of MRI in
relation to planning CT in 12 lung cancer patients.
The hypothesis is that the use of 4D MRI will be more accurate in defining the tumour and
intrathoracic structures thanachieved with the current standard of 4DCT to improve the
accuracy and potentially the outcome of radical radiotherapy for non-small cell lung cancer.
Description:
Firstly, 3 stage III NSCLC patients receiving radiotherapy will be imaged, each for a single
MRI session using TWIST and HASTE sequences. Initial sequence parameters will be those
determined during the preceding technical development, but these will be fine-tuned to
maximize tumour visualisation as this part of the study progresses, achieving the most
practically useful trade-off between image resolution and noise, qualitatively and
quantitatively assessed by a radiologist to determine and fine-tune image quality.
Then a further 12 patients will be imaged, each for two MRI sessions taking place during the
radiotherapy schedule and separated by at least a week. Each MR session will consist of the
following sequence: 15 seconds of TWIST, 15 seconds of HASTE, 90 seconds off, 15 seconds of
TWIST and 15 seconds of HASTE. For each patient an on-treatment 4D cone-beam CT will also be
collected (standard process), alongside the diagnostic quality planning 4DCT. Patient
breathing coaching will be consistent between CT and MR, as will patient positioning; that
is, patients will be imaged with their arms above their heads. The images will be analyzed to
determine -
1. Do extents of tumour movement seen in TWIST 4D-MR images differ from those seen in
planning 4D-CT scans, judging the movement extent according to differences in internal
target and gross tumour volumes (ITVs and GTVs) defined from the two sets of images, and
in the range of motion of the tumour centre of mass? This may well be the case, since
the 4D-MR scans catalogue movement over several breathing cycles, whereas 4D-CTs
describe a single composite cycle, synthesised from slices collected at various times
over multiple cycles.
2. How reproducible is the movement seen at the two MR imaging sessions? Additionally, how
reproducible is the movement seen within each MR imaging session?
3. How similar according to volume, Dice similarity index (percentage of overlap) and
Haussdorf distance (maximum distance between the contours of two structures) are GTVs
outlined on single phases of 4D-CT and TWIST 4D-MR images, after rigidly registering the
centres-of-mass of the two GTVs to allow for movement?
4. How consonant are tumour contours defined on single slice HASTE MR images with those
defined on a phase of the 4D TWIST images? Answering question 1 will allow us to
determine the utility of gauging tumour movement over extended 4D-MR imaging sessions,
rather than from 4D-CT sessions which have to be short to avoid excessively irradiating
patients. Question 2 will cast further light on the same issue, allowing us to determine
the stability over the course of RT schedules of motion assessed over the course of
around 1 minute during an individual TWIST scan.
Answering question 3 will allow us to understand how fully 4D-MR images can be used within
the treatment planning process. If outlined GTVs differ greatly between MRI and CT, then
4D-MRI might only provide more complete movement data; whereas if CT and MRI-based GTVs are
similar the 4D-MRI may have more uses in treatment planning, particularly if some tumour
regions are more clearly visible on MRI than on CT.
Question 4 will allow us to gauge the accuracy and precision of tumour definition on
real-time single MRI slices, compared to definition on 4D-MR and 4D-CT. Answering this
question is an essential precursor to the development of automatic algorithms
