Clinical trial: NCT02479100
Section: Confidentiality
Subsections: 12. **Will My Taking Part In This Study Be Kept Confidential?**

All information collected about you as a result of your participation in the study will be kept strictly confidential. Your personal and medical information will be kept in a secured file and be treated in the strictest confidence. You may ask to see your personal information at any time and correct any errors if necessary. Once you have agreed to participate in this study you will be allocated a unique study number which will be used on all your study documentation. This number will be linked to your personal information; however you will only be identified by this unique number. Data and images made available to GE Healthcare at the end of the study will be anonymised to comply with data protection and patient confidentiality. We will need to inform your GP of your participation in this study so that any medical decisions made by your GP account for any treatment you are receiving as part of this study.  
Authorised staff, who work for or with the sponsor of the study, the hospital R&D Department or the Regulatory Agency responsible for drug research may require access to your personal information and/or medical records to verify the data for this study and ensure that it is being conducted in accordance with UK law. All information will be treated in the strictest confidence during the review process.
Clinical trial: NCT02479100
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 7. **What Are The Possible Benefits Of Taking Part?**|11. What If There Is A Problem?

There is no guarantee that you will benefit from taking part in this study. It is probable that undertaking the CESM procedure will help in the assessment of your breasts. Also, information collected as part of your participation in this study may benefit patients with suspected breast disease in the future.

Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. If you have any concerns about any aspect of this study you should speak to your study doctor who will do their best to answer your questions. In the event that something does go wrong and you are harmed by taking part in the research and this is due to someone's negligence then you may have grounds for a legal action for compensation against Addenbrookes Hospital or the University of Cambridge. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).The University has obtained insurance which provides no-fault compensation i.e. for non-negligent harm, you may be entitled to make a claim for this. If you wish to complain or have any concerns about any aspect of the way you have been approached or treated during this study, you can do this through the NHS complaints procedure. In the first instance it may be helpful to contact the Patient Advice and Liaison Service (PALS) at Cambridge University Hospitals NHS Foundation Trust:
Patient Advice and Liaison Service, Box 53, Cambridge University Hospitals, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ
Tel: *01223 216 756* Email: pals@addenbrookes.nhs.uk
Clinical trial: NCT02479100
Section: Procedures
Subsections: 5. **What Will Happen To Me If I Take Part?**|Prior To Cesm Procedure|Csem Procedure|Following The Procedure

If you agree to participate in the study, you will be asked to sign the Informed Consent Form at the end of this document. You will be given a copy of this to take away and refer to later.  
We put people into two groups - one group will receive standard care and the other will receive CESM in addition to standard care. You will be allocated one of the groups for this trial in a random way (by chance), much like flipping a coin. You will have a 50% chance of receiving CESM in addition to standard care.

If you are put into the group who will undergo CESM in addition to standard care you will be asked to complete a short questionnaire (yes/no answers) about your health and any previous x-ray examinations with contrast media (dye). You will also need to have a finger-prick blood test so we can check how well your kidneys are working.

The aim is to carry out the procedure on the same day as your clinic visit. This will be dependent upon time, staff available and your own circumstances. If necessary an appointment will be made to carry out the procedure within the next week. There is no preparation required for the procedure.  
The equipment used and the positioning is exactly the same as for a routine mammogram.  
You will be given an injection of contrast media (dye) into your arm. This is the same type of contrast media used routinely in CT scanning. Two minutes after the injection the radiographer will position you and take pictures in each of the four routine mammography positions.  
From the injection of the contrast media the procedure should only take around 10 minutes. You will be asked to remain in the department for 15 minutes afterwards.

If CESM identifies any additional area of suspicion in your breast, a core biopsy from that area will need to be taken in addition to one from the original area of suspicion. Once the biopsies have been performed you will return to standard care procedures.  
6. **What are the possible disadvantages and risks of taking part?**
You may need to undergo the procedure at an additional hospital visit.
It is likely you may experience some bruising at the site of the injection. It is also possible that you may suffer an allergic reaction to the contrast media (dye). This contrast agent is the same agent used for all iodine based intravenous contrast used in the Radiology Department in the hospital.  
After injection into an artery or vein, it is uncommon (1% risk = 1-10 in 1,0000) to experience pain and discomfort Rare effects (0.1% risk=1-10 in 10,000) include diarrhoea, irregular heartbeat, kidney problems, cough, fever, general discomfort or dizziness Very rare (0.01%=less than1in 10,000) include seizures (fits), clouding consciousness, disturbance of senses like touch, trembling, flushing, difficulty breathing including severe breathing difficulty due to fluid in your lungs ,short term brain disorders(encephalopathy), short term memory loss, coma and stupor or myocardial infarction .  
Minor reactions, e.g. skin rashes, hives, itching, nausea, dizziness, runny nose, brief retching and /or vomiting; will be closely monitored by Breast Unit staff until symptoms have alleviated or further action is needed. Staff in the room will summon additional help - including a Radiologist - by means of alarmed pull cord.  
Moderate reactions e.g. headache, persistent vomiting, wheezing, palpitations, facial swelling, raised blood pressure (hypertension), abdominal cramps; may require an injection of antihistamine and/or adrenaline. A pack of emergency drugs for this purpose will be kept in the room where the CESM
procedure is carried out. In the exceptional event of a serious reaction which has the potential to be life-threatening, e.g. difficulty breathing, chest pain, irregular heartbeat, collapse, seizure, cardiac arrest; staff will make an urgent call the hospital's emergency resuscitation team. The CESM procedure involves an additional dose of radiation which is roughly equivalent to that received on a long haul flight to New Zealand or 20 chest x-rays.
Clinical trial: NCT02479100
Section: Purpose of Research
Subsections: Section 1: Purpose Of The Study And What Will Happen 1. **What Is The Purpose Of The Study?**

This is a pilot study looking at a new way of imaging the breasts called Contrast Enhanced Spectral Mammography (CESM) and whether it can provide additional information to help with diagnosis. The study will compare the results from patients undergoing CESM in addition to standard care with those from patients undergoing standard care alone to see if those who have CESM are given their final diagnosis sooner.  
2. What is standard care?  
Standard care may include further mammography, ultrasound, a clinical examination, magnetic resonance imaging (MRI) and biopsy dependent upon findings in each individual case. Results of any biopsies taken are discussed at a weekly multidisciplinary team meeting (MDT) where a decision is made regarding the next steps in patient care or diagnosis. CESM will be in addition to any procedure undertaken as standard care.  
3. **Why have I been invited?**
You have been invited to participate in this trial because you have been shown to have an area of suspicion in your breast and we aim to investigate whether CESM would be a suitable procedure to assist in your diagnosis. We plan to include 100 participants from this hospital.
Clinical trial: NCT02479100
Section: Voluntary Participation
Subsections: 4. Do I Have To Take Part?

Participating in this trial is completely voluntary. If you decide to participate you will be asked to sign an Informed Consent Form, however you are still free to change your mind and leave the study at any time without giving a reason. If you chose not to participate or to leave the study, your future medical treatment and normal standard of care will not be affected in any way.