Contact information
Type
Scientific
Primary contact
Prof Vicky Goh
ORCID ID
http://orcid.org/0000-0002-2321-8091
Contact details
Division of Imaging Sciences & Biomedical Engineering
King’s College London
Level 1
Lambeth wing
St. Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)207 188 5538
vicky.goh@kcl.ac.uk
Type
Scientific
Additional contact
Prof Gary Cook
ORCID ID
Contact details
Division of Imaging Sciences & Biomedical Engineering
King’s College London
Level 1
Lambeth wing
St. Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)207 188 5538
gary.cook@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31962
Study information
Scientific title
Evaluation of treatment response and resistance in metastatic renal cell cancer (mRCC) using integrated 18F-Fluorodeoxyglucose (18F-FDG) positron emission tomography/magnetic resonance imaging (PET/MRI): The REMAP study
Acronym
REMAP
Study hypothesis
PET/MRI improves response classification compared to routine CT imaging in metastatic renal cell carcinoma.
Ethics approval
Southeast London Research Ethics Committee, 10/10/2016, ref: 16/LO/1499
Study design
Randomised; Interventional; Design type: Diagnosis, Process of Care, Imaging
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Specialty: Cancer, Primary sub-specialty: Renal; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract
Intervention
Participants with metastatic renal cell cancer will undergo FDG PET/MRI scans at baseline, 12 and 24 weeks following the start of their standard treatment and results compared to the routine clinical CT scans at these time-points. Each PET/MRI will take approximately one hour. The imaging intervention is over 24 weeks and the imaging follow up period extends to the 36 week clinical CT scan. Subsequent consensus panel assessment of clinical and all imaging data up to 36-weeks will confirm disease status.
Intervention type
Other
Phase
Drug names
Primary outcome measures
disease response or non-response measured by PET/MRI and CT at 12 and 24 weeks and clinical examination and CT at 36 weeks.
Secondary outcome measures
Time to progression will be measured by clinical examination and CT at standard three to six monthly follow up clinic visits.
Overall trial start date
16/05/2015
Overall trial end date
01/02/2020
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients (male or female > 18 years old) with metastatic renal cell carcinoma
2. Metastases with ≥1 measurable sites, ≥2cm, planned for targeted therapy
3. ECOG performance status 0-2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 38; UK Sample Size: 38
Participant exclusion criteria
1. Contraindications to contrast-enhanced MRI or CT or FDG PET including renal impairment eGFR <50
2. Estimated prognosis < 12 weeks
3. ECOG performance status > 2
4. Previous radiotherapy
Recruitment start date
01/12/2016
Recruitment end date
01/11/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King’s College London and Guy’s and St Thomas’ PET Centre
Level 1, Lambeth wing
St. Thomas’ Hospital
Guy’s and St. Thomas’ NHS foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Trial participating centre
Mount Vernon Cancer Centre
East and North Hertfordshire NHS trust
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Preliminary/interim results of the study will be disseminated by conference presentation during the trial and the final results submitted for publication in relevant peer reviewed journals where applicable within a year of the trial end date.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Vicky Goh (vicky.goh@kl.ac.uk)
Intention to publish date
01/02/2021
Participant level data
Available on request
Results - basic reporting
Publication summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28578690
Publication citations
Additional files
- ISRCTN12114913_PIS_29Jun2016_V1.1.docx Uploaded 16/11/2016