Assessing response to treatment using imaging with PET/MRI in advanced renal cancer

ISRCTN ISRCTN12114913
DOI https://doi.org/10.1186/ISRCTN12114913
Secondary identifying numbers 31962
Submission date
02/11/2016
Registration date
16/11/2016
Last edited
13/07/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-pet-mri-scans-for-people-with-kidney-cancer-that-has-spread-remap

Contact information

Prof Vicky Goh
Scientific

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

ORCiD logoORCID ID 0000-0002-2321-8091
Phone +44 (0)207 188 5538
Email vicky.goh@kcl.ac.uk
Prof Gary Cook
Scientific

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

Phone +44 (0)207 188 5538
Email gary.cook@kcl.ac.uk

Study information

Study designRandomised; Interventional; Design type: Diagnosis, Process of Care, Imaging
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet ISRCTN12114913_PIS_29Jun2016_V1.1.docx
Scientific titleEvaluation 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
Study acronymREMAP
Study hypothesisPET/MRI improves response classification compared to routine CT imaging in metastatic renal cell carcinoma.
Ethics approval(s)Southeast London Research Ethics Committee, 10/10/2016, ref: 16/LO/1499
ConditionRenal cell carcinoma
InterventionParticipants 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 typeOther
Primary outcome measuredisease 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 measuresTime to progression will be measured by clinical examination and CT at standard three to six monthly follow up clinic visits.
Overall study start date16/05/2015
Overall study end date01/02/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 38; UK Sample Size: 38
Participant inclusion criteria1. 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 exclusion criteria1. 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 date01/12/2016
Recruitment end date31/07/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

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
Mount Vernon Cancer Centre
East and North Hertfordshire NHS trust
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Sponsor information

King's College London
University/education

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

ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date01/02/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPreliminary/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 planThe 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)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V1.1 29/06/2016 16/11/2016 No Yes
Protocol article protocol 02/06/2017 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN12114913_PIS_29Jun2016_V1.1.docx
Uploaded 16/11/2016

Editorial Notes

13/07/2022: Recruitment has resumed.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
06/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 01/11/2019 to 31/07/2022.
2. The overall trial end date has been changed from 01/02/2020 to 01/02/2023.
3. The intention to publish date has been changed from 01/02/2021 to 01/02/2024.
28/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Renal; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract" to "Renal cell carcinoma" following a request from the NIHR.
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.