Condition category
Cancer
Date applied
27/01/2020
Date assigned
12/02/2020
Last edited
12/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

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 participants 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 March 2022

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?
Adedayo Oke, Adedayo.Oke@gstt.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vicky Goh

ORCID ID

Contact details

King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
+44 (0)207 188 5550
vicky.goh@kcl.ac.uk

Type

Scientific

Additional contact

Dr Olwen Westerland

ORCID ID

Contact details

King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
+44 (0)207 188 5550
Olwen.Westerland@gstt.nhs.uk

Type

Public

Additional contact

Dr Adedayo Oke

ORCID ID

Contact details

Department of Clinical Imaging and Medical Physics
Floor 4
Lambeth Wing
St. Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
+44 (0)207 188 8381
adedayo.oke@gstt.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 32545, IRAS 199518

Study information

Scientific title

Response evaluation in myeloma patients using integrated 18F-Fluorodeoxyglucose (18F-FDG) positron emission tomography/magnetic resonance imaging (PET/MRI)

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

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

Study design

Non-randomised; Interventional; Design type: Diagnosis, Imaging

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

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

Phase

Drug names

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 trial start date

01/10/2016

Overall trial end date

01/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Newly diagnosed with myeloma

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

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

01/09/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
Guy's and St Thomas' NHS Foundation Trust Great Maze Pond Rd
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Research Management and Innovation Office
Room 5.23
James Clerk Maxwell Building
Waterloo Campus
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)207 848 6960
keith.brennan@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Other

Funder name

Royal College of Radiologists

Alternative name(s)

RCR

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/01/2020: Trial's existence confirmed by the National Institute for Health Research (NIHR).