Is a PET/MRI scan better than a PET/CT scan at visualising bone lesions and their change with treatment in adults with myeloma?
| ISRCTN | ISRCTN15606951 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15606951 |
| IRAS number | 199518 |
| Secondary identifying numbers | CPMS 32545, IRAS 199518 |
- Submission date
- 27/01/2020
- Registration date
- 12/02/2020
- Last edited
- 28/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-pet-mri-scan-to-pet-ct-scan-for-spotting-bone-damage-caused-by-myeloma-revamp
Background and study aims
Myeloma, a form of blood cancer, is a debilitating disease affecting 4,800 patients per year in the UK. Patients suffer from bone pain because the cancer causes bone to be destroyed. Scans and X-rays are used to create images of the bone so that the holes can be detected and measured. This is important in deciding which treatments to use and assessing how well the treatment is working. A new type of scanning method called PET/MRI might be able to show where the myeloma is most active, before there is bone destruction. This study will compare PET/MRI with another scanning method, PET/CT, in patients with myeloma who are going to be treated with a bone marrow transplant.
Who can participate?
Adults who have been newly diagnosed with myeloma
What does the study involve?
Participants will be assessed and treated as usual, except that they will have a PET/MRI scan as well as each standard PET/CT scan, so that the two scanning methods can be compared. The scans will be done before the start of treatment and after the chemotherapy that participants have before the bone marrow transplant.
What are the possible benefits and risks of participating?
Risks:
1. Participants will be required to fast for up to 6 hours prior to each PET scan. The researchers will assess the fasting for safety and will take measures, for example adjusting diabetes medication, to reduce the risks.
2. Participants will be required to lie still for up to 1 hour during the scans. They will be warned that they may experience some discomfort particularly if they have bone disease, and of course can discontinue the test if it is too uncomfortable.
3. There is a small risk of side effects from the contrast agent that is injected into the participant's vein before the scan to make structures inside their body more visible on the image. Participants will fill in a questionnaire before the procedure to enable the researchers to assess whether they might have higher risk of reactions and take appropriate actions to reduce this risk.
4. The PET/CT scan involves being exposed to radiation, which carries a small risk of side effects. This will be explained to the participants, along with measures to reduce risk.
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
October 2016 to October 2026
Who is funding the study?
The National Institute for Health Research (NIHR) (UK) and the Royal College of Radiologists (UK)
Who is the main contact?
Miss Chimtom Nwaosu, chimtom.nwaosu@gstt.nhs.uk
Contact information
Scientific
King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
| Phone | +44 (0)207 188 5550 |
|---|---|
| vicky.goh@kcl.ac.uk |
Scientific
King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
| Phone | +44 (0)207 188 5550 |
|---|---|
| Olwen.Westerland@gstt.nhs.uk |
Public
C/O Non-Ionising Radiation Team
3rd Floor Mezzanine
South Wing
St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)7701234816 |
|---|---|
| chimtom.nwaosu@gstt.nhs.uk |
Study information
| Study design | Non-randomized; Interventional; Design type: Diagnosis, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | Response evaluation in myeloma patients using integrated 18F-Fluorodeoxyglucose (18F-FDG) positron emission tomography/magnetic resonance imaging (PET/MRI) |
| Study acronym | REVAMP |
| Study hypothesis | Myeloma, a form of blood cancer, is a debilitating disease affecting 4,800 patients per year [CRUK 2014]. Patients suffer from bone pain due to destructive bone lesions. Imaging plays an important role via lesion detection, therapy triage and response assessment. Skeletal survey, involving x-rays of the entire skeleton [Dimopoulos, Blood, 2011] has been the 'gold standard' but recent studies have shown it only has a sensitivity of 30% for lesion detection [Regelink et al, 2013]. Magnetic resonance imaging (MRI) may improve on this (80% versus 30% sensitivity, [Regelink, 2013]). Whole body MRI, where the skeleton can be imaged from skull base to knees, is now possible and recommended in the 2015 International Myeloma Working Group (IMWG) guidelines for baseline staging in myeloma [Dimopoulos, 2015]. For treatment response assessment a study has suggested that FDG PET/CT may better than MRI alone for assessment of response/non-response [Spinnato, 2012]]. Position Emission Tomography/MR (PET/MRI) is a new scanner that combines MRI and PET imaging. PET may highlight myeloma as areas of increased glucose metabolism, whilst the MR component provides an anatomic map. We hypothesize that PET/MRI will improve staging and treatment response assessment. We wish to evaluate newly diagnosed myeloma patients planned for bone marrow transplantation, and compare this to PET/CT. We will develop software to quantify tumour volume pre- and post-induction chemotherapy and to assess changes in tumour function/composition e.g. metabolism, cellularity and fat content, as we hypothesize that these may change with treatment. |
| Ethics approval(s) | Approved 14/10/2016, South Central - Hampshire A Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol BS1 2NT; +44 (0)117 342 1328; nrescommittee.southcentral-hampshirea@nhs.net), ref: 16/SC/0428 |
| Condition | Myeloma |
| Intervention | Participants will be identified, screened and approached. Participants will be consented by the clinical team, research team or appropriately trained delegates. PET/CT and PET/MR appointments will be booked (pre- and post-induction chemotherapy) and safety questionnaires completed. Standard clinical pre-treatment assessments will also take place. Participants will undergo a baseline standard-of-care PET/CT and additional research PET/MRI prior to treatment commencing. They will then undergo a standard-of-care post-treatment PET/CT and additional research PET/MRI within 4-6 weeks following completion of induction chemotherapy. Patients will have further treatment (which may include bone marrow transplant) and follow-up assessment as determined by the direct clinical care team. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Myeloma bone disease detection, calculated using using focal lesion number, MRI bone marrow pattern and functional parameters including SUVmax, ADC and fat fraction parameters, assessed by PET/CT and PET/MRI at baseline and at 4-6 weeks following completion of induction chemotherapy 2. Treatment response calculated using using focal lesion number, MRI bone marrow pattern and functional parameters including SUVmax, ADC and fat fraction parameters, assessed by PET/CT and PET/MRI at baseline and at 4-6 weeks following completion of induction chemotherapy 3. Response/non-response to treatment assessed using clinical biomarkers and clinical review following completion of induction chemotherapy and following bone marrow transplant, including 100-day post-transplant bone marrow biopsy, where performed. Patients will be followed up by the clinical haematology team as per standard clinical practice. |
| Secondary outcome measures | - |
| Overall study start date | 01/10/2016 |
| Overall study end date | 01/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Participant inclusion criteria | Newly diagnosed with myeloma |
| Participant exclusion criteria | 1. Contraindication to PET/CT or PET/MR 2. Unable to provide informed consent. |
| Recruitment start date | 04/01/2017 |
| Recruitment end date | 01/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Great Maze Pond Rd
London
SE1 9RT
United Kingdom
Sponsor information
University/education
Research Management and Innovation Office
Room 5.23
James Clerk Maxwell Building
Waterloo Campus
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)207 848 6960 |
|---|---|
| keith.brennan@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- The Royal College of Radiologists, RCR
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | At the end of the study, the results will be presented at meetings and published in a high-impact peer-reviewed journal. All information will be anonymous and at no time will it be possible for patients to be identified individually. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.6 | 01/04/2022 | 13/07/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 1.7 | 23/05/2023 | 17/10/2023 | No | No |
Additional files
Editorial Notes
28/02/2025: Contact details updated.
17/10/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2023 to 01/10/2025.
2. The overall end date was changed from 01/10/2024 to 01/10/2026.
3. The intention to publish date was changed from 01/03/2025 to 01/10/2027.
4. The plain English summary was updated to reflect these changes.
5. Uploaded protocol v1.7 (not peer-reviewed) as an additional file.
13/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/09/2021 to 01/10/2023.
2. The overall trial end date has been changed from 01/03/2022 to 01/10/2024 and the plain English summary updated accordingly.
3. Recruitment has resumed.
4. A protocol file has been uploaded.
5. The intention to publish date has been changed from 01/03/2023 to 01/03/2025.
30/12/2021: Cancer Research UK plain English summary link added to plain English summary field
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
30/01/2020: Trial's existence confirmed by the National Institute for Health Research (NIHR).
