Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study

Not Applicable

Completed

• Conditions: Locally Advanced Cervical Cancer
• Interventions: Diagnostic Test: lymphatic mapping

• Registration Number: NCT05746156
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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?

Study Timeline

• Study Start: 2020-07-20
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Status Verified: 2023-02
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lymphatic map	lymphatic mapping	Lymphatic mapping will be performed

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?	2 years	comparison to RT treatment plan

Trial Locations

Locations (1)

Amsterdam UMC University of Amsterdam; 🇳🇱 Amsterdam, Netherlands