Biological magnetic resonance imaging parameters in cancer

ISRCTN	ISRCTN12676704
DOI	https://doi.org/10.1186/ISRCTN12676704
Secondary identifying numbers	33659

Submission date: 14/08/2017
Registration date: 24/08/2017
Last edited: 23/04/2021

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 of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-a-new-type-of-mri-scan-for-people-having-radiotherapy-for-throat-cancer-biopic

Contact information

Dr Nigar Syed
Scientific

Oxford Imaging Trials Unit
Department of Radiology
Surgical And Diagnostic Building
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Study information

Study design	Non-randomised; Both; Design type: Diagnosis, Process of Care, Imaging, Cohort study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Biological magnetic resonance imaging parameters in oropharyngeal squamous cell carcinoma (BIOPIC): a non-randomised study
Study acronym	BIOPIC
Study objectives	This study will investigate new MRI scanning techniques in patients undergoing radiotherapy treatment for squamous cell oropharyngeal (head and neck) cancer. We are looking at whether there are any changes in the cancer when the patient breathes in additional oxygen or carbogen (oxygen with carbon dioxide). This is important as tumours with low oxygen tend to be less responsive to treatment with chemotherapy or radiotherapy. We are also looking at a new method of imaging glucose (sugar) as this is taken up by cancer cells more than normal cells. We currently use FDG-PET/CT scans to image glucose but this involves radiation, unlike MRI. Patients will be asked to have an extra MRI scan before, during and after treatment to look at changes seen with the new MRI techniques we are investigating. We will also be taking blood samples and accessing tissue samples, such as routine biopsies taken as part of clinical care. We will look at the changes that occur with treatment, both under the microscope and through genetic testing. We will then compare this information to the findings from the MRI scans and other scans done routinely as part of patient care. We are interested to see if the new MRI techniques might be useful to monitor cancer patients having treatment or to predict whether they are likely to respond to therapy. In future this may allow us to choose the right treatment for a patient or to modify a treatment to improve response. This study is funded by the Oxford Cancer Imaging Centre and the Oxfordshire Health Services Research Committee. Recruitment will take place at the Churchill Hospital, Oxford.
Ethics approval(s)	Gwasanaeth Moeseg Ymchwil Research Ethics Service, 08/02/2017, ref: 17/WA/0033
Health condition(s) or problem(s) studied	Specialty: Cancer, Primary sub-specialty: Head and Neck Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of lip, oral cavity and pharynx
Intervention	This is an observational study to assess novel MRI imaging techniques T1 and T2* with supplemental oxygen and carbogen breathing and CEST. Baseline scans will be compared to imaging during and post treatment in patients undergoing radiotherapy for oropharyngeal squamous cell carcinoma. For glucoCEST, comparison to DCE-MRI and contemporaneous clinical FDG-PET will also be undertaken. An exploratory study will investigate immunohistochemical and genetic markers related to factors influencing response to radiotherapy and compare these to findings on imaging. Patient will be recruited from a single centre (Oxford University Hospital Foundation Trust) and will receive standard treatment and follow-up as part of routine NHS care. 15 patients (group A) will undergo study MRI lasting no more than one hour at three time points (baseline, during and after radiotherapy). A subgroup of participants (group B) will have an additional MRI at baseline i.e. 4 study MRI scans in total. Every patient who agrees to participate in the study and is felt by the investigator to be suitable will be asked if they are willing to be part of group B until a total of 5 participants is reached. From seeking informed consent, patients will be followed until post-treatment imaging which takes place 10-12 weeks after completion of radiotherapy. The duration of patients participation will be approximately 4 months.
Intervention type	Other
Primary outcome measure	Changes in tumour T1 and T2* imaging with supplemental oxygen at baseline, week 2 radiotherapy and 10 weeks post radiotherapy
Secondary outcome measures	1. CEST signal with and without supplemental oxygen, measured at baseline, week 2 RT and 10 weeks post RT 2. T1, T2* and CEST signal with supplemental carbogen, measured at baseline, week 2 RT and 10 weeks post RT 3. Changes in GlucoCEST pre & post glucose load and markers such as choline, creatine, lactate, APT, measured at baseline, week 2 RT and 10 weeks post RT 4. FDG-PET parameters including SUVmax, uptake volume, measured at baseline and 10 weeks post RT 5. Standard DCE-MRI parameters such as ktrans, Ve, AUC compared with dynamic glucoCEST signal changes such as AUC, measured at baseline, week 2 RT and 10 weeks post RT 6. Consistency of MRI parameter measurements, evaluated using test-retest imaging at baseline in a subgroup of participants
Overall study start date	07/06/2016
Completion date	31/05/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 20; UK Sample Size: 20
Key inclusion criteria	1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. HPV-positive oropharyngeal squamous cell carcinoma for treatment with radical radiotherapy +/- systemic therapy 4. The tumour is at least T2 or if nodal disease is used as the treatment assessment site, the node is at least 2 cm in minimum diameter on MRI 5. In the Investigator’s opinion, is able and willing to comply with all study requirements 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study 7. Involvement in other clinical studies is acceptable
Key exclusion criteria	1. Female participant who is pregnant, lactating or planning pregnancy during the course of the study 2. Significant renal or hepatic impairment 3. Type 1 diabetes mellitus or poorly controlled T2 diabetes mellitus or fasting capillary/venous blood glucose level > 8mmol/L. 4. Ongoing supplemental oxygen as part of clinical care 5. Known lung disease with carbon dioxide retention, chronic obstructive airways disease with known or at risk of hypercapnia 6. Most recent available arterial blood gas (ABG) from the current hospital admission demonstrates hypoxia or hypercapnia on room air 7. Any patient not felt to be suitable for supplemental oxygen or carbogen as considered by an appropriately trained clinician 8. Contraindication to MRI (e.g. cardiac pacemaker, ferromagnetic cerebral aneurysm clip, metallic foreign body in the eye) 9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
Date of first enrolment	24/04/2017
Date of final enrolment	06/09/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oxford Imaging Trials Unit

OX3 7LE
United Kingdom

Sponsor information

University of Oxford
University/education

Clinical Trials and Research Governance
University of Oxford
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom

"ROR"	https://ror.org/052gg0110

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 date	31/05/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	The intention is to publish this research in a specialist peer reviewed scientific journal on completion of the study. The results may also be presented at scientific meetings and/or used for a thesis. No study results may be published or presented without the prior approval of the TMG. Intend to publish before one year after overall trial end date.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version V03	21/10/2016	02/04/2019	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN12676704_PROTOCOL_V03_21Oct16.pdf: Uploaded 02/04/2019

Editorial Notes

23/04/2021: Proactive update review. No publications found.
02/04/2019: Uploaded protocol (not peer reviewed).
18/10/2018: The following changes were made:
1. The overall trial end date was changed from 06/09/2019 to 31/05/2019
2. The intention to publish date was changed from 06/09/2020 to 31/05/2020
13/06/2018: Cancer Research UK lay summary link added to plain English summary field
14/05/2018: Internal review.
13/04/2018: Internal review
16/01/2018: Internal review.
25/10/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
16/10/2017: Internal review.