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
Plain English summary of protocol
Contact information
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 ID |
0000-0002-2321-8091 |
|---|---|
| Phone | +44 (0)207 188 5538 |
| vicky.goh@kcl.ac.uk |
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 |
|---|---|
| gary.cook@kcl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Diagnosis, Process of Care, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN12114913_PIS_29Jun2016_V1.1.docx |
| 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 |
| Study acronym | REMAP |
| Study objectives | PET/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 |
| Health condition(s) or problem(s) studied | Renal cell carcinoma |
| 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 |
| 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 study start date | 16/05/2015 |
| Completion date | 01/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 38; UK Sample Size: 38 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2016 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St. Thomas’ Hospital
Guy’s and St. Thomas’ NHS foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Sponsor information
University/education
Guy’s Campus
King’s College London
London
SE1 4UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Charity
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 date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
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.
