La educación para la crítica y la resistencia: Un camino a explorar

Patient Information Sheet

The Role of Positron Emission Tomography (PET) in the Pre operative Assessment of Patients with Colorectal Cancer

You are invited to take part in a research project. You do not have to take part in this study if you do not want to. If you do decide to take part you may withdraw at any time without having to give any reason. Your decision whether to take part or not will not affect your care and management in any way. A ll proposals for research using human subjects are reviewed by an ethics committee before they can proceed. This proposal was reviewed by the joint UCI7UCLH Committees on Ethics o f Human Research.

1. This study aims to estabhsh if positron emission tomography (PET) scans are better than conventional computerised tomography (CT) scans at detecting the extent o f spread o f bowel cancer.

2. It is routine practice to perform a CT scan and blood tests prior to surgical treatment o f bowel cancer. These tests aim to detect the extent o f spread o f cancer cells from the main tumour in the bowel. The information from these tests and laboratory analysis o f the tumour after it is removed gives doctors the necessary information with regard to microscopic spread. This will allow the most appropriate treatment to deal with an individual patients cancer to be chosen The information, therefore, influences the extent o f surgery performed and possibly the use o f other treatments such as chemotherapy or radiotherapy.

3. Some patients may develop a recurrence o f the cancer due to the presence and spread o f

microscopic cancer cells. If PET scans are shown to detect microscopic spread earher than current tests the treatment chosen may be altered accordingly This may result in fewer patients developing a recurrent cancer. Patients who take part in this study will have a PET scan (described below) in addition to normal treatment. This will not directly affect the treatment for your cancer.

Description o f the research study:

Prior to your admission to hospital for surgery you will undergo a CT scan and blood test (to measure a marker o f your cancer in the blood called carcinoembryonic antigen (CEA)). These tests are part o f the normal preparation for surgery. You will be admitted to hospital two days prior to your operation in order to prepare your bowel for surgery. On the day before your surgery you w ill have a PET scan in the Institute o f Nuclear Medicine in the Middlesex hospital. The procedure w ill entail you having to fast for a period o f four hours (so that glucose that you consume in your diet will not interfere with the PET scan). Once you are in the Institute o f Nuclear Medicine you will be given an injection o f glucose which has been labelled with a radioactive substance, through a cannula (plastic tube) in a vein. You would need a cannula in one o f your veins (usually forearm) for your surgery in any case. The radioactivity lasts approximately 90 minutes, therefore you do not have to wait for the scan. You will have to lie on a platform \\hich m oves you into the scanner. The scan takes one hour and you will need to lie still. Once the scan is complete you w ill return to your ward and prepare for your surgery on the following day as explained to you by your doctors. At the operation the surgeon will make a thorough examination and document the findings. A tiny fragment o f the cancer and surrounding tissue will be taken for examination by one o f the doctors involved in the study. Cancers need growth promoting agents as well as a blood supply therefore particular attention will be paid to the presence o f these factors. The main part o f the tissue which is removed w ill be sent for analysis by a pathologist as is the usual practise. A comparison w ill be made between the CT scan and PET scan findings to see if there is in fact any difference. Both scan findings w ill then be related to the analysis o f the tissue removed. You w ill be looked after in your ward by your doctors and recovery will be as explained to you by them.

CONFIDENTIAL

Consent Form

STUDY TITLE; The role of Positron Emission Tomography (PET) in the pre operative assessment of patients with colorectal cancer

PATIENT NAME: HOSPITAL NUMBER: WARD/ ADDRESS:

By signing this form I agree that:

1. I have read the patients information sheet and the procedure has been fully explained to me. 2. I have had the opportunity to ask questions and I did receive satisfactor): answers.

3. I have been given a copy o f the information sheet and the consent form to keep.

4. I understand that I am participating in a research study and I understand the risks and benefits involved. I freely give my consent to participate in the research study outlined in the patient information sheet.

5. I understand that I may withdraw from this research study at any time without giving a reason for withdrawing and such a decision would not affect the standard o f care that 1 receive in any way.

Signature o f participant... Date.../ .../ ...

Name o f participant (Block Capitals). Investigator Statement

1 have carefully explained to the above named patient the nature o f the research protocol. I hereby certify that to the best o f my knowledge the subject signing this form understands the nature, demands, risks and benefits involved in participating in this study.

Signature o f investigator... Name o f investigator (Block Capitals). Date.../ ... / ... Signature o f witness... Name o f witness (Block Capitals). Date... / .../ ...

Principal investigator : Prof. I. Taylor ( tel: 0207-504-9312)

CONFIDENTIAL

Patient Information Sheet

The Role of Positron Emission Tomography