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Completed

NCT Number: NCT05746156

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

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)

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Key information

Conditions

Locally Advanced Cervical Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC University of Amsterdam

Amsterdam, 1100DD, Netherlands

About this study

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:

  • 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?
  • Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lymphatic mapping

Diagnostic Test
  • 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.
  • Planair and SPECT/CT imaging van de abdomen/pelvis 3h and 12-24h after injection at the department of radiology and nucleair medicine.

Primary outcomes

  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?

    Time frame: 2 years

    feasibiliy

Secondary outcomes

  1. Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?

    Time frame: 2 years

    comparison to RT treatment plan

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

Lymphatic Mapping for Image Guided Radiotherapy in Patients With Locally Advanced Cervical Cancer, a Feasibility Study

Acronym: LaMA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2023
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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