Lymphoma, HodgkinMELTNCT01459224
MELT - MRI Evaluation of Lymphoma Treatment
An observational study of Lymphoma, Hodgkin, run by University College, London at 1 site in United Kingdom.
Trial summary
Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis… Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Lymphoma, Hodgkin
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Oct 2015
- 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 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hodgkin's Lymphoma
Who may be able to join
- Aged 5 to 20 years (inclusive) with participant and parent/guardian informed consent
- Histologically confirmed first presentation of Hodgkin's Lymphoma
- Either entered into the Euronet PHL-C1 trial or LP1 trials OR not formally entered into the Euronet trials but treated on the chemotherapy regimens of the Euronet trials for classical and lymphocyte predominant Hodgkin Lymphoma
Who cannot join
- Contraindications to MRI (e.g. pacemaker)
- Previous malignancy or previous chemotherapy or radiotherapy treatment for malignancy
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Body Functional and Anatomical MRI: Accuracy in Staging and Treatment Response Monitoring in Adolescent Hodgkin's Lymphoma Compared to Conventional Multimodality Imaging
Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an extended MRI scan.
Read the detailed description
The trial will be a single centre cohort study in patients newly diagnosed with Hodgkin's lymphoma undergoing disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo advanced anatomical and functional MRI sequences.
- Conditions
- Lymphoma, Hodgkin
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The per site sensitivity and specificity of MRI for both nodal and extranodal sites and concordance in final disease stage with the multi-modality reference standard
Measured: The recruited patients to be followed up for 1 year
Secondary outcomes (5)
The number of correct patient classifications into therapy responders and non-responders by MRI compared to the multi modality reference
Measured: The recruited patients to be followed up for 1 year
Inter observer agreement for MRI between reporting radiologists (on site and off site). responders by MRI compared to the multi modality reference
Measured: The recruited patients to be followed up for 1 year
Sensitivity, specificity of qualitative assessment of Minimum intensity projection (MIP) inverted high B value datasets
Measured: The recruited patients to be followed up for 1 year
Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease
Measured: The recruited patients to be followed up for 1 year
Simulated effect of MRI on clinical management via external oncologic review
Measured: The recruited patients to be followed up for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, HodgkinStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart A Taylor, Prof, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459224
- Sponsor's protocol ID
- UCL10/0271
- Other IDs
- CRUK ASC 12707
- Acronym
- MELT
- Status last verified
- Dec 2015
- First submitted
- 19 Oct 2011
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Functional and Anatomical MRI: Accuracy in Staging and Treatment Response Monitoring in Adolescent Hodgkin's Lymphoma Compared to Conventional Multimodality Imaging
- ClinicalTrials.gov ID
- NCT01459224
- Acronym / sponsor ID
- MELT / UCL10/0271
- Conditions
- Lymphoma, Hodgkin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Oct 2011 (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.
Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an extended MRI scan.
Detailed description
The trial will be a single centre cohort study in patients newly diagnosed with Hodgkin's lymphoma undergoing disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo advanced anatomical and functional MRI sequences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hodgkin's Lymphoma
Key inclusion criteria (3 listed)
- Aged 5 to 20 years (inclusive) with participant and parent/guardian informed consent
- Histologically confirmed first presentation of Hodgkin's Lymphoma
- Either entered into the Euronet PHL-C1 trial or LP1 trials OR not formally entered into the Euronet trials but treated on the chemotherapy regimens of the Euronet trials for classical and lymphocyte predominant Hodgkin Lymphoma
Key exclusion criteria (3 listed)
- Contraindications to MRI (e.g. pacemaker)
- Previous malignancy or previous chemotherapy or radiotherapy treatment for malignancy
- Pregnancy 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.
Primary outcome
The per site sensitivity and specificity of MRI for both nodal and extranodal sites and concordance in final disease stage with the multi-modality reference standard
Time frame: The recruited patients to be followed up for 1 year
5 secondary outcomes
The number of correct patient classifications into therapy responders and non-responders by MRI compared to the multi modality reference
Time frame: The recruited patients to be followed up for 1 year
Inter observer agreement for MRI between reporting radiologists (on site and off site). responders by MRI compared to the multi modality reference
Time frame: The recruited patients to be followed up for 1 year
Sensitivity, specificity of qualitative assessment of Minimum intensity projection (MIP) inverted high B value datasets
Time frame: The recruited patients to be followed up for 1 year
Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease
Time frame: The recruited patients to be followed up for 1 year
Simulated effect of MRI on clinical management via external oncologic review
Time frame: The recruited patients to be followed up for 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Coordinating Centre WebsiteLink provided by the sponsor.
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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.
Stuart A Taylor, Prof principal investigator
University College London Hospitals
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, Hodgkin, 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: finished, as of the sponsor's last update on 3 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The per site sensitivity and specificity of MRI for both nodal and extranodal sites and concordance in final disease stage with the multi-modality reference standard (time frame: The recruited patients to be followed up for 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 3 Dec 2015.