None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to assess the feasibility and accuracy of using core biopsies to diagnose uterine masses at two hospital centres. Who is it for? You are eligible for this study if you are aged 18 years or over, are not pregnant and have a uterine mass at least 5cm or greater with either rapid growth on sequential assessment, suspicious features on MRI or have known or suspected cancer predisposition syndromes including pathogenic mutations in BRCA1 or BRCA2 and mismatch repair genes (Lynch syndrome). Study details All those who are eligible will undergo a one-off percutaneous uterine needle biopsy (PUB) which will be performed by the treating gynecology oncologist at the hospital site where you are being treated. A comparison will be made with the findings from your resected specimen as part of the planned surgery. If surgery is not performed then the comparator will be the clinical course of the uterine mass at 6 and 12 month clinical follow up visits. If you are not eligible for PUB prior to surgery then you may still have the option to participate by consenting to a biopsy of your removed uterine mass. The cases contributed via this alternate pathway will help to improve the determination of the accuracy and reliability of core biopsies. It is hoped that the results from this study will help explore the possibility of using core biopsies for diagnosis of uterine masses, particularly for women who wish to preserve their fertility.
Interventions
A one-off percutaneous uterine needle biopsy (PUB) will be performed on the participant by a gynecology oncologist at the hospital site where the patient is being treated. The PUB procedure will be carried out in line with usual practice for core biopsies of pelvic, retroperitoneal and intra-abdominal sarcomas. PUB is a day procedure typically taking 10 to 15 minutes to complete and involves sophisticated imaging techniques (eg ultrasound, CT or MRI) to localise the area of the tumour. Then, und
A one-off percutaneous uterine needle biopsy (PUB) will be performed on the participant by a gynecology oncologist at the hospital site where the patient is being treated. The PUB procedure will be carried out in line with usual practice for core biopsies of pelvic, retroperitoneal and intra-abdominal sarcomas. PUB is a day procedure typically taking 10 to 15 minutes to complete and involves sophisticated imaging techniques (eg ultrasound, CT or MRI) to localise the area of the tumour. Then, under local anaesthesia, a small cylinder with a cutting chamber is inserted into the mass to remove multiple small cores of that tissue for pathologists to examine. For this study, PUBs will be performed with the coaxial technique using 14 or 16-gauge semiautomatic cutting needles (Bard ‘‘Mission’’ disposable core biopsy instrument). The needles utilised will be 10 to 15-cm long with 20 mm penetration depth. A minimum 4 but preferably 6 samples will be obtained from each mass in all patients. Adherence to the intervention will be confirmed via review of medical records. The timing of the procedure will occur according to specialist recommendation and will not delay the scheduling of any recommended surgery. The biopsy results will be discussed at the GYN Oncology MDT in order to determine the next step in the patient’s management which may or may not include surgery. The MDT’s recommendations will be discussed with the patient at her scheduled post procedure clinic visit. Results and the decisions made will be reviewed from the medical records and recorded in the study database.
Sponsors
Australia and New Zealand Sarcoma Association
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Not pregnant 2. Age greater than or equal to 18 years 3. Women with known or suspected cancer predisposition syndromes including pathogenic mutations in BRCA1 or BRCA2 and mismatch repair genes (Lynch syndrome) are eligible 4. Uterine mass greater than or equal to 5cm at baseline with rapid growth on sequential assessment, or suspicious features on MRI
Exclusion criteria
1. Inability to give informed consent. 2. The radiologists’ expert opinion is that the particular lesion is technically unsuitable for PUB 3. Bleeding tendency. 4. Serious concurrent comorbidities that in the surgeon’s or radiologist’s opinion would pose a contraindication to PUB.
Outcome results
None listed