LymphomaPET/MRINCT02935348
Whole Body PET-MRI in Paediatric and Adolescent Lymphoma
An observational study of Lymphoma, run by University College, London at 1 site in United Kingdom.
Trial summary
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment. Investigators want to investigate if a combined PET-MRI scan could give the same information. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Whole Body MRI
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Childhood and adolescent cases of clinically suspected or histologically confirmed Hodgkin Lymphoma
Who may be able to join
- Suspected or histologically confirmed Hodgkin lymphoma
- Male or female participants
- Age 0-20 years inclusive
- Entered into the EuroNet PHL-C1 trial, LP1 trial or successor Euronet trials, including Euronet PHL C2 due to open from 2013 onwards or planned to receive chemotherapy regimens of said trials without being formally entered into the trial.
- Participant/Guardian/Parental written informed consent
Who cannot join
- Participants with contraindications to MRI (including cardiac pacemakers or non-MRI compatible intracranial vascular clips)
- Participants who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Centre for Medical Imaging
London, London, NW1 2PG
Joey J Clemente, 02034479194 ext. 79094, joey.clemente@uclh.nhs.uk
About this study
Official title: Feasibility of Using Whole Body PET-MRI to Stage and Restage Paediatric and Adolescent Hodgkin Lymphoma - a Pilot Study
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.
Investigators want to investigate if a combined PET-MRI scan could give the same information.
Children who join our study will have an extra scan twice during their treatment
Read the detailed description
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.
Investigators want to investigate if a combined PET-MRI scan could give the same information.
Children who join our study will have an extra scan twice during their treatment
Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.
- Conditions
- Lymphoma
- Being tested
- Whole Body MRI
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body MRIRadiation
Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigator will determine the technical feasibility of performing functional co-registered combined PET-MRI in this patient group using diffusion-weighted MR imaging.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startFeb 2014
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Humphries, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935348
- Sponsor's protocol ID
- 13/0268
- Acronym
- PET/MRI
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Whole Body PET-MRI to Stage and Restage Paediatric and Adolescent Hodgkin Lymphoma - a Pilot Study
- ClinicalTrials.gov ID
- NCT02935348
- Acronym / sponsor ID
- PET/MRI / 13/0268
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- 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.
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.
Investigators want to investigate if a combined PET-MRI scan could give the same information.
Children who join our study will have an extra scan twice during their treatment
Detailed description
Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.
Investigators want to investigate if a combined PET-MRI scan could give the same information.
Children who join our study will have an extra scan twice during their treatment
Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Childhood and adolescent cases of clinically suspected or histologically confirmed Hodgkin Lymphoma
Key inclusion criteria (5 listed)
- Suspected or histologically confirmed Hodgkin lymphoma
- Male or female participants
- Age 0-20 years inclusive
- Entered into the EuroNet PHL-C1 trial, LP1 trial or successor Euronet trials, including Euronet PHL C2 due to open from 2013 onwards or planned to receive chemotherapy regimens of said trials without being formally entered into the trial.
- Participant/Guardian/Parental written informed consent
Key exclusion criteria (2 listed)
- Participants with contraindications to MRI (including cardiac pacemakers or non-MRI compatible intracranial vascular clips)
- Participants who are pregnant or nursing
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 |
|---|---|---|
| Whole Body MRIRoutine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration. | Radiation | – |
Primary outcome
The investigator will determine the technical feasibility of performing functional co-registered combined PET-MRI in this patient group using diffusion-weighted MR imaging.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Paul Humphries principal investigator
UCL
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 Lymphoma, 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joey J Clemente (02034479094 ext. 79094, joey.clemente@uclh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The investigator will determine the technical feasibility of performing functional co-registered combined PET-MRI in this patient group using diffusion-weighted MR imaging. (time frame: 3 years). 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 17 Oct 2016.