HealthyNCT05943249
Development of Novel MR Techniques Using Volunteer Participants
An observational study of Healthy, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- magnetic resonance
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2007to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participant with the relevant condition Participant without condition Pre-condition Professionals Carers Relations Other Diagnostic, screening or prevention participants Genetically predisposed
Who may be able to join
- Healthy volunteers will be recruited by email from within departments at UCL and UCLH
- male or female
- Aged 18 and above
Who cannot join
- volunteers with pacemakers or other implanted devices, or with other metallic foreign bodies, will be excluded.
- Women who may be pregnant
- any participants who cannot give informed consent (including anyone who may not adequately understand the verbal explanations or written information given in English)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neela Ramchurn contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London
Dr Shonit Punwani, 02035495663, shonit.punwani@nhs.net
Dr Shonit Punwani, PhD, FRCR
About this study
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.
Read more
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.
Read the detailed 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.)
- Conditions
- Healthy
- Being tested
- magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonanceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of novel MR techniques
New protocols will be developed and validated to be used in clinical research, and to provide volunteer data for ongoing research into magnetic resonance techniques: improving the speed, quality, and range of measurements possible with the scanner.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start4 Jun 2007
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943249
- Sponsor's protocol ID
- 3T000175
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel MR Techniques Using Volunteer Participants
- ClinicalTrials.gov ID
- NCT05943249
- Acronym / sponsor ID
- 3T000175
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 4 Jun 2007 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.)
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant with the relevant condition Participant without condition Pre-condition Professionals Carers Relations Other Diagnostic, screening or prevention participants Genetically predisposed
Key inclusion criteria (3 listed)
- Healthy volunteers will be recruited by email from within departments at UCL and UCLH
- male or female
- Aged 18 and above
Key exclusion criteria (3 listed)
- volunteers with pacemakers or other implanted devices, or with other metallic foreign bodies, will be excluded.
- Women who may be pregnant
- any participants who cannot give informed consent (including anyone who may not adequately understand the verbal explanations or written information given in English)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance | Procedure or surgery | – |
Primary outcome
Development of novel MR techniques
Time frame: 1 year
New protocols will be developed and validated to be used in clinical research, and to provide volunteer data for ongoing research into magnetic resonance techniques: improving the speed, quality, and range of measurements possible with the scanner.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neela Ramchurn contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neela Ramchurn (n.ramchurn1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of novel MR techniques (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.