Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05943249 |
| Other study ID # |
3T000175 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 4, 2007 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University College, London |
| Contact |
Neela Ramchurn |
| Email |
n.ramchurn1[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Using magnetic resonance (MR) imaging or spectroscopy as part of clinical research typically
involves developing new MR protocols. Although some of this work is done by scanning
artificial 'phantoms', volunteer studies are normally needed to configure and validate new
protocols appropriately.
Developing new MR protocols and techniques is also useful in its own right. The volunteer
scanning described in this application will provide data to support this type of
methodological research into new scanning and image processing techniques: improving the
speed, quality, and range of measurements possible with the scanner.
With proper safety and screening procedures, MR has no known side-effects, and has been
performed on millions of human subjects worldwide without ill effect. There are
well-established contraindications for MRI, and screening procedures are already in place in
the MR unit at UCLH to exclude such subjects and ensure the safety of subjects. With these,
and the MR scanner's built in safety mechanisms, residual risk is low. Many other trusts with
active MR research have previously made similar applications to this related to volunteer MR
scanning for pilot work and methodological research
Although scans may obtained as part of several research projects, in each case it is only the
scanning technique (the programmed sequence of data acquisition and processing steps) which
will vary, along with the body region to be imaged. The volunteer experience will be very
similar, and all ethical issues, including the information sheet and consent form, will be
identical. These scans are for methodological research on the MR techniques themselves, and
will be never form part of the volunteer's own healthcare. Separate ethical permission is
sought for any study which does not match the above criteria.
Description:
We are applying for general permission to acquire magnetic resonance (MR) data from normal
volunteers. Data will be used to develop and test MR protocols for subsequent clinical
research, and to support methodological research into MR techniques: improving the speed,
quality, and range of measurements possible with the scanner. This application is restricted
to the non-invasive imaging of healthy adults. It excludes interventional MR procedures,
injections of MR contrast agents, and all other invasive techniques. MR imaging has been
performed on millions of subjects worldwide without ill effect: there are well-established
contraindications for MR, particularly associated with metal in the body, and when these are
followed residual risk is low. Scans will be performed on commercially available MR systems
at UCLH, with their internal monitoring and safety devices always enabled. Scans will be
connected with several research projects, but in each case it is the scanning technique (the
programmed sequence of data acquisition and processing steps) which will vary. The volunteer
experience will be similar, and all ethical and consent details will be identical. These
scans are for methodological research on the MR techniques themselves, and will never form
part of the volunteer's own healthcare. Volunteers will normally be recruited from within the
medical physics department. Before scanning, the volunteer will undergo safety screening (a
questionnaire, backed up by explanation from an MR radiographer or experienced MR physicist).
If there are no contraindications to the scan, the volunteer will then be placed on a table
inside the MR scanner. Ear protection will be provided. Occasionally, small temporary surface
makers (usually ordinary cod liver oil capsules) may be placed on the volunteer's skin to
allow positions to be identified between scans. Appropriate MR coils (receivers in plastic
moldings, connected to the scanner by a cable) will usually be placed around the body part
being imaged. Imaging will be carried out for a variable period of time not exceeding two
hours. During the procedure, the volunteer may sometimes be asked to hold their breath or
move in certain ways. Microphones, speakers, and an emergency buzzer allow the volunteer to
remain in verbal contact with the person operating the scanner, and to request that the scan
be terminated at any time for any reason. Normally, individual scans are independent.
Occasionally a volunteer may be asked in advance to attend for more than one scan, to check
that a newly designed measurement is reproducible across different visits. (It is
anticipated, however, that some individuals will volunteer for several independent scans.)
