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A Feasibility Study Of The Role Of Sentinel Lymph Node Detection In The Management Of Patients With Apparent Early Stage Endometrial Cancer

A Feasibility Study Of The Role Of Sentinel Lymph Node Detection In The Management Of Patients With Apparent Early Stage Endometrial Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001279819
Enrollment
50
Registered
2012-12-11
Start date
2012-08-13
Completion date
2014-05-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this pilot study is to assess the feasibility of sentinel lymph node detection in patients with apparent early stage endometrial carcinoma in the Australia setting. The hypothesis is that carrying out SLN detection in women with presumed early stage endometrial cancer, would prevent the morbidity associated with a formal pelvic lymph node dissection while attempting to identify the cohort that will be upstaged on final pathology. This will help to identify the women who could potentially benefit from adjuvant radiotherapy in preventing a loco-regional recurrence following the management of endometrial cancer. This feasibility study will help us determine if SLN detection is feasible in women with low risk endometrial cancer.

Interventions

The intra-cervical injection technique using radio-colloid and Patent Blue dye will be used for SLN mapping. The radio-colloid injection will be carried out on the day of the procedure and pre-operative lymphoscintigraphy with SPECT-CT will be obtained. Patients who have consented to the trial will be brought to the Nuclear Medicine Department at Royal Melbourne Hospital on the day of their planned surgery. In a similar manner to performing a pap smear, the cervix will be injected with 2mls of t

The intra-cervical injection technique using radio-colloid and Patent Blue dye will be used for SLN mapping. The radio-colloid injection will be carried out on the day of the procedure and pre-operative lymphoscintigraphy with SPECT-CT will be obtained. Patients who have consented to the trial will be brought to the Nuclear Medicine Department at Royal Melbourne Hospital on the day of their planned surgery. In a similar manner to performing a pap smear, the cervix will be injected with 2mls of the radiocolloid, Technetium 99 at the 12, 3, 6 and 9 o’clock position. After the speculum is removed the patients will be asked to complete a Visual Analogue Score to assess pain related to the injection. The SPECT-CT will then be performed to track the route and nodal uptake of the radiocolloid and this information will be returned with the patient to the operating theatre. Under general anaesthetic after initial inspection of the peritoneal cavity, a gamma probe will be used to locate any hot nodes (at least 10 x the background activity). Two millilitres of Patent Blue dye will be injected into the cervix at the 3 and 9 o’clock positions. The SLN biopsy will be carried out prior to the hysterectomy and any nodes which are hot, blue, or both hot and blue will be removed and be set aside for separate histological examination. Hot nodes will be confirmed ex vivo (by counting activity for 3 to 10 seconds) and the nodal basins will be checked for any further nodes. All identified sentinel nodes will be removed and their location noted. Women with presumed low risk disease will undergo a hysterectomy and bilateral salpingo-oophorectomy and only SLN identified at the time of the procedure will be removed.

Sponsors

Royal Women's Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Histologically confirmed endometrial cancer Histologically confirmed complex atypical endometrial hyperplasia Written informed consent

Exclusion criteria

Suspected lymph node metastasis on preoperative MRI based on pre-set criteria Any contra-indications to formal staging surgery e.g. co-morbidities Inability to give informed consent Poor understanding of English in absence of an interpreter Inaccessible for follow up Allergy to isotope or dye used Previous cervical surgery like conisation Age = 18 years Evidence of metastatic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026