A study looking for changes in PET-CT scans of women with ovarian, fallopian or primary peritoneal cancer that has come back

Please note this trial is no longer recruiting patients.

This study is looking for early changes that may show up in PET-CT scans of women with ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has come back (relapsed).

Doctors often use chemotherapy to treat ovarian cancer that has come back. They usually do a CT scan, after about 3 cycles of chemotherapy to see if the treatment is working.

As chemotherapy has side effects it is better to find out as soon as possible if the treatment is helping. If it is not working as well as the doctors hope, they can stop treatment or make changes, depending on the situation.

PET scans are a different type of scan. Doctors usually use these to measure the spread of cancer. They don’t currently use them to see how well chemotherapy is working

The researchers want to combine the PET scan and the CT scan into 1 scan called a PET-CT scan.

The aim of this study is to find out if a PET-CT scan is better than a CT scan alone at showing how well chemotherapy is working for women with relapsed ovarian, fallopian tube or primary peritoneal cancer.

Recruitment

Start 20/10/2009

End 31/01/2011

Phase

Phase 1

Who can enter

You can enter this study if

You have epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has come back (relapsed) and can be seen on a CT scan
You have had carboplatin or cisplatin (platinum drugs) before
Your cancer has come back 6 months or more after you have had carboplatin or cisplatin
You are having carboplatin or cisplatin again to treat your cancer
You are well enough to take part in this trial (performance status 0, 1, 2)
Your kidneys work well enough to take part in this trial
You have gone through the menopause and have not had a period for 2 years OR you and your partner are willing to use reliable contraception if there is a chance you may become pregnant
You are 35 years or older

You cannot enter this study if you

Have had surgery to the tummy (abdomen) in the last 6 weeks
Have had radiotherapy to the tummy or the area between your hips (pelvis) in the last 6 months
Have a blockage in the bowel (bowel obstruction) that has not gone away
Are having, or have had, another drug as a part of a clinical trial in the last 30 days before starting treatment in this trial
Have diabetes that is not well controlled (your morning sugar level is greater than 8.3 mmol/L)
Have another serious medical condition that could affect you taking part in this trial
Are pregnant

Trial design

Doctors hope to recruit 20 to 40 women into this study in 2 UK hospitals. Everyone taking part will have chemotherapy to treat their cancer.

In this study, everyone will have 4 or 5 PET-CT scans. You will have a scan

Before you start chemotherapy
After the 1st cycle of chemotherapy
After the 2nd cycle of chemotherapy
After you have finished chemotherapy

Those having 5 scans in total will have two scans before they start chemotherapy.

Two weeks after the last PET-CT scan, the researchers will telephone you to ask how you are.

You will have a CT scan after 3 cycles of chemotherapy. You would have this scan even if you were not taking part in this study.

You will have another CT scan 9 months after starting chemotherapy. This is for the researchers.

Hospital visits

You will have 5 or 6 extra visits to the hospital as a part of this study. Each visit will last about 3 hours in total.

You have your first PET-CT scan a few days before you start chemotherapy. You cannot eat anything for 4 hours before the scan.

Firstly, you will have a fine needle put into a vein in your arm to give the radioactive ‘tracer’.

Before taking the scan, the researchers will take a small amount of blood to measure your blood sugar levels. If your blood sugar levels are too high, to give the radioactive ‘tracer’, the researchers will ask you to wait for a few hours.

This will be repeated each time you have a PET-CT scan.