None listed
Conditions
Brief summary
This study aims to compare if magnetic resonance imaging (MRI) is equivalent to a diagnostic laparoscopy as a tool for finding macroscopic (visible to the eye) ovarian cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or older with advanced ovarian, primary peritoneal or fallopian tube cancer. Study details All participants in this study will have MRI performed, which takes approximately one hour. This will be done either before chemotherapy, midway through chemotherapy, or both. At the time of your MRI, two radiologists (doctors who specialise in imaging) will calculate a score based on how much cancer is visible. You will then have your scheduled diagnostic laparoscopy (keyhole surgery) within two weeks of your MRI. If you are having laparoscopy only, then the surgery is likely to take approximately 30 minutes and you would be in hospital for a few hours. Based on the laparoscopy, the surgeon will calculate a cancer burden score. The MRI and laparoscopy scores will be compared for the purpose of this study. It is hoped this research will determine if MRI is able to replace laparoscopy in assessing cancer, which would allow risk and patient burden to be reduced.
Interventions
Participant’s cases will be discussed at a gynaecological tumour board (at the participating hospitals of Chris O'Brien Lifehouse and Royal Women's Hospital), determining suitability for upfront cytoreduction versus neoadjuvant chemotherapy.
Participants for whom more clinical information or a tissue diagnosis is required will undergo diffusion-weighted magnetic resonance imaging (DW-MRI) (1 hour) and laparoscopy (30 minutes). The laparoscopy will occur within two weeks of the MRI. Two indepen
Participant’s cases will be discussed at a gynaecological tumour board (at the participating hospitals of Chris O'Brien Lifehouse and Royal Women's Hospital), determining suitability for upfront cytoreduction versus neoadjuvant chemotherapy. Participants for whom more clinical information or a tissue diagnosis is required will undergo diffusion-weighted magnetic resonance imaging (DW-MRI) (1 hour) and laparoscopy (30 minutes). The laparoscopy will occur within two weeks of the MRI. Two independent radiologists will calculate a PCI score, blinded from the other radiologist and the gynaecological oncological surgeon who subsequently performs the laparoscopically scored PCI. All PCI scores will be recorded and compared. Participants recommended to have neoadjuvant chemotherapy (either at tumour board or post laparoscopy) will have routine NACT under the care of a medical oncologist. Following 2-3 cycles of NACT, imaging will be performed to determine if they are suitable for cytoreductive surgery. Routine standard of care would be imaging with a CT, whereas study participants will have a DW-MRI. Once again two independent radiologists will calculate a PCI score based on the participant’s DW-MRI, with the score being blinded from each other and the laparoscopic surgeon. The only change to standard care is the addition of one, or possibly two, preoperative DW-MRI three weeks prior to major surgery and within two weeks of diagnostic laparoscopy. The timeframe is important to limit change to disease status between imaging and surgery. Following surgery, participants will return to routine standard of care with completion of a further 2-3 cycles of chemotherapy and routine follow-up surveillance. Participants will be assessed at the time of imaging and at all subsequent follow-up visits for side effects secondary to participation in the study.
Sponsors
Chris O'Brien Lifehouse (Sydney Local Health District)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Age greater than or equal to 18 years old 2) FIGO stage 3 ovarian cancer 3) Histologically or cytologically proven primary epithelial ovarian, primary peritoneal or fallopian tube carcinoma (including serous papillary adenocarcinoma, adenocarcinoma and endometrioid adenocarcinoma) 4) Willingness to provide written informed consent and participate in the study
Exclusion criteria
1) Diagnosis other than ovarian cancer 2) Previous abdominal malignancy or tuberculosis 3) Severe claustrophobia 4) MR (magnetic resonance) contrast allergy 5) Hip replacement or spinal hardware 6) Renal failure of either acute or chronic nature which precludes contrast administration
Outcome results
None listed