Locally Advanced Cervical Cancer
Conditions
Brief summary
Lymphatic mapping is a procedure in which all lymph nodes with drainage from the primary tumor, i.e. all nodes with potential (micro)metastases, can be imaged. These nodes are not necessarily suspicious on other imaging techniques. The goal of this feasibility study is to 1. investigate the feasibility of the lymphatic mapping procedure in locally advanced cervical cancer 2. study the agreement of the lymphatic map with the radiotherapy treatment plan including previous imaging (MRI / CT / FDG-PET/CT)
Detailed description
Study population: Aged ≥18 years, with locally advanced cervical cancer, that will be planned for radiotherapy. Intervention (if applicable): Lymphatic mapping will be performed on all study patients during the standard investigation under anaesthesia, to ensure painless injection of the radiopharmaceutical. Patients will receive 6-8 depots of \[99mTc\]Tc-nanocolloid peritumoral. Planar and SPECT/CT gamma camera images will be made at the department of Radiology and Nuclear medicine 3 hours and 12-24 hours after administration of the radiopharmaceutical. All radioactive lymph nodes will be included in the lymphatic map. The radiation oncologist will determine the radiation therapy treatment plan blinded to the data of the lymphatic mapping. The lymphatic map will be compared to the radiation treatment plan and previous imaging (MRI / CT / FDG-PET/CT). Main study parameters/endpoints: 1. Is it feasible to perform lymphatic mapping in locally advanced cervical cancer? Is there visualisation of (multiple) lymph nodes in both sides of the tumor? 2. Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?
Interventions
DIAGNOSTIC_TESTlymphatic mapping
1. Peritumoral injection of \[99mTc\]Tc-nanocolloid in 6-8 evenly distributed depots on both sides of the tumor, during investigation under anaesthesia. Number of depots depending on the size and localisation of the tumor. 2. Planair and SPECT/CT imaging van de abdomen/pelvis 3h and 12-24h after injection at the department of radiology and nucleair medicine.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Results of the lymphatic map will be blinded to the radiation oncologist
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically proven locally advanced cervical cancer \[FIGO stage IIB-IVA\]. \>18 years old. Treatment with curative (chemo)radiation. Signed informed consent.
Exclusion criteria
Pregnancy. Administration of the radioactive tracer cannot be ensured properly due to obesity Patients with tumors in which no circumferential injection of \[99mTc\]Tc-nanocolloid is possible due to the size or position of the tumor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Is it feasible to perform lymphatic mapping in locally advanced cervical cancer? Is there visualisation of (multiple) lymph nodes in both sides of the tumor? | 2 years | feasibiliy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan? | 2 years | comparison to RT treatment plan |
Countries
Netherlands
Outcome results
None listed