None listed
Conditions
Brief summary
The purpose of this study is to determine the feasibility of an imaging technique in assessing the spread of cancer in women with cancer of the uterus. Who is it for? You may be eligible for this study if you are a female, over the age of 18, and have been diagnosed with Stage 1 or 2 cancer of the uterus. Study details All patients with early stage endometrial cancer at the Mater Adult Hospital in South Brisbane that are being treated with surgery will undergo sentinel lymph node mapping as part of their staging surgery. The sentinel lymph nodes will then be submitted to the pathologist for analysis. Patients will not need to undergo further tests or follow ups after this. There will be no special blood tests required for this study. All participants will have the routine bloods taken which are needed for surgery. It is hoped that this research will show that sentinel lymph node mapping can safely replace traditional full pelvic lymph node removal in selected women with endometrial cancer.
Interventions
Sentinel lymph node mapping procedure using indocyanine green (ICG) fluorescent dye injected into the cervix and near infra-red fluorescence (NIRF) imaging during laparoscopic or robotic staging surgery for apparent early stage endometrial cancer,
All patients with apparent early stage endometrial cancer treated with surgery at Mater Hospital will undergo sentinel lymph node mapping as part of their staging surgery. This will involve injection of 4ml of ICG (1.25mg/ml) into the cervix after i
Sentinel lymph node mapping procedure using indocyanine green (ICG) fluorescent dye injected into the cervix and near infra-red fluorescence (NIRF) imaging during laparoscopic or robotic staging surgery for apparent early stage endometrial cancer, All patients with apparent early stage endometrial cancer treated with surgery at Mater Hospital will undergo sentinel lymph node mapping as part of their staging surgery. This will involve injection of 4ml of ICG (1.25mg/ml) into the cervix after induction of anaesthesia and use of NIRF imaging with laparoscopic or robotic platform to visualise and remove sentinel lymph node(s) from each hemi-pelvis. The sentinel lymph nodes will be submitted to pathological ultra-staging. Data on primary tumour and sentinel lymph node detection, location and pathology findings will be recorded prospectively. yes all patients currently undergo sentinel node mapping as standard care patients will be followed up for 3 years (36 months). Patients will be reviewed post surgery in the usual manner to assess for recurrence of their disease.
Sponsors
Dept. Of Gynaecological Oncology Mater Adults Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Clinically FIGO Stage 1 or Stage 2 disease (disease that is clinically and radiologically confined to the uterus with no evidence of nodal or distant metastatic disease). - Patient over 18 years and able to give informed consent.
Exclusion criteria
- Current pregnancy or desire to retain fertility. - Clinical or radiological evidence of extra-uterine disease including lymphadenopathy. - Previous hysterectomy or treatment of endometrial cancer by radiotherapy, chemotherapy or hormonal therapy. - Any contra-indication to comprehensive lymph-node staging. - Patient declining any form of lymph node assessment or staging. - Contra-indication to receiving indocyanine green dye including history of hepatic impairment or an iodine allergy. - Inaccessible to follow-up.
Outcome results
None listed