Condition category
Cancer
Date applied
02/11/2016
Date assigned
16/11/2016
Last edited
19/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measure

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 (if study stopped)

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

Sponsor information

Organisation

King's College London

Sponsor details

Guy’s Campus
King’s College London
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

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

Basic results (scientific)

Publication list

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28578690

Publication citations

Additional files

Editorial Notes

19/10/2017: Publication reference added. 06/06/2017: Cancer Help UK lay summary link added to plain English summary field 18/11/2016: Professor Gary Cook has been added as a scientific contact for this study.