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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lymphatic map | Experimental | Lymphatic mapping will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lymphatic mapping | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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? | feasibiliy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan? | comparison to RT treatment plan | 2 years |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC University of Amsterdam | Amsterdam | 1100DD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37306763 | Derived | Adam JA, Poel E, van Eck-Smit BLF, Mom CH, Stalpers LJA, Stoker J, Bipat S. Lymphatic mapping for image-guided radiotherapy in patients with locally advanced uterine cervical cancer: a feasibility study. EJNMMI Res. 2023 Jun 12;13(1):58. doi: 10.1186/s13550-023-00989-0. |
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Results of the lymphatic map will be blinded to the radiation oncologist
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|